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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02229851
Registration number
NCT02229851
Ethics application status
Date submitted
26/08/2014
Date registered
3/09/2014
Date last updated
23/11/2020
Titles & IDs
Public title
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
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Scientific title
A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
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Secondary ID [1]
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2013-002892-16
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Secondary ID [2]
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NN8640-4054
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Universal Trial Number (UTN)
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Trial acronym
REAL 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Disorder
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Adult Growth Hormone Deficiency
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - somapacitan
Treatment: Drugs - somatropin
Treatment: Drugs - placebo
Experimental: NNC0195-0092 (somapacitan) -
Active Comparator: Daily hGH -
Placebo Comparator: Placebo - Switch to NNC0195-0092 (somapacitan) treatment in the extension period.
Treatment: Drugs: somapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
Treatment: Drugs: somatropin
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Truncal Fat Percentage (Week 34)
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Assessment method [1]
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Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [1]
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Week -3, week 34
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Secondary outcome [1]
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Change in Truncal Fat Percentage (Week 87)
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Assessment method [1]
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Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [1]
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week -3, week 87
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Secondary outcome [2]
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Change in Truncal Fat Mass (Week 34)
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Assessment method [2]
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Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [2]
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Week -3, week 34
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Secondary outcome [3]
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Change in Truncal Fat Mass (Week 87)
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Assessment method [3]
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Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [3]
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week -3, week 87
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Secondary outcome [4]
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Change in Truncal Lean Body Mass (Week 34)
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Assessment method [4]
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Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [4]
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Week -3, week 34
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Secondary outcome [5]
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Change in Truncal Lean Body Mass (Week 87)
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Assessment method [5]
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Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [5]
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week -3, week 87
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Secondary outcome [6]
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Change in Total Fat Mass (Week 34)
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Assessment method [6]
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Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [6]
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Week -3, week 34
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Secondary outcome [7]
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Change in Total Fat Mass (Week 87)
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Assessment method [7]
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Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [7]
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Week -3, week 87
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Secondary outcome [8]
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Change in Visceral Adipose Tissue (Week 34)
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Assessment method [8]
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Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [8]
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Week -3, week 34
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Secondary outcome [9]
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Change in Visceral Adipose Tissue (Week 87)
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Assessment method [9]
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Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [9]
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Week -3, week 87
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Secondary outcome [10]
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Change in Android Fat Mass (Week 34)
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Assessment method [10]
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Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [10]
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Week -3, week 34
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Secondary outcome [11]
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Change in Android Fat Mass (Week 87)
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Assessment method [11]
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Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [11]
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week -3, week 87
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Secondary outcome [12]
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Change in Gynoid Fat Mass (Week 34)
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Assessment method [12]
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Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [12]
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Week -3, week 34
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Secondary outcome [13]
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Change in Gynoid Fat Mass (Week 87)
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Assessment method [13]
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Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [13]
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week -3, week 87
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Secondary outcome [14]
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Change in Appendicular Skeletal Muscle Mass (Week 34)
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Assessment method [14]
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Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [14]
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Week -3, week 34
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Secondary outcome [15]
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Change in Appendicular Skeletal Muscle Mass (Week 87)
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Assessment method [15]
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Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [15]
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week -3, week 87
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Secondary outcome [16]
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Change in Lean Body Mass (Week 34)
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Assessment method [16]
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Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [16]
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Week -3, week 34
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Secondary outcome [17]
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Change in Lean Body Mass (Week 87)
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Assessment method [17]
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Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [17]
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week -3, week 87
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Secondary outcome [18]
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Change in Bone Mineral Content (Week 87)
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Assessment method [18]
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Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [18]
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week -3, week 87
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Secondary outcome [19]
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Change in Bone Mineral Density (Week 87)
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Assessment method [19]
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Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [19]
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week -3, week 87
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Secondary outcome [20]
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Change in IGF-I SDS (Week 34)
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Assessment method [20]
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Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
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Timepoint [20]
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Week -3, week 34
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Secondary outcome [21]
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Change in IGF-I SDS (Week 87)
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Assessment method [21]
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Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.
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Timepoint [21]
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Week -3, week 87
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Secondary outcome [22]
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Change in IGFBP 3 SDS (Week 34)
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Assessment method [22]
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Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [22]
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Week -3, week 34
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Secondary outcome [23]
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Change in IGFBP 3 SDS (Week 87)
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Assessment method [23]
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Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [23]
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Week -3, week 87
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Secondary outcome [24]
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Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
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Assessment method [24]
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Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
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Timepoint [24]
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Week 0, week 34
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Secondary outcome [25]
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Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
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Assessment method [25]
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Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
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Timepoint [25]
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week 0, week 87
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Secondary outcome [26]
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Change in SF-36v2 (Summary and Domain Scores) (Week 34)
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Assessment method [26]
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SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
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Timepoint [26]
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Week 0, week 34
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Secondary outcome [27]
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Change in SF-36v2 (Summary and Domain Scores) (Week 87)
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Assessment method [27]
0
0
SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
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Timepoint [27]
0
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week 0, week 87
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Secondary outcome [28]
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TSQM-9 Scores (Domain Scores) (Week 34)
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Assessment method [28]
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Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
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Timepoint [28]
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Week 34
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Secondary outcome [29]
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TSQM-9 Scores (Domain Scores) (Week 87)
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Assessment method [29]
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Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
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Timepoint [29]
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Week 87
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Secondary outcome [30]
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Change in Total Cholesterol (Week 34)
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Assessment method [30]
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Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [30]
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Week -3, week 34
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Secondary outcome [31]
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Change in Total Cholesterol (Week 87)
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Assessment method [31]
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Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [31]
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week -3, week 87
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Secondary outcome [32]
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Change in HDL-cholesterol (Week 34)
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Assessment method [32]
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Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [32]
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Week -3, week 34
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Secondary outcome [33]
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Change in HDL-cholesterol (Week 87)
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Assessment method [33]
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Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [33]
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week -3, week 87
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Secondary outcome [34]
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Change in LDL-cholesterol (Week 34)
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Assessment method [34]
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Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [34]
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Week -3, week 34
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Secondary outcome [35]
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Change in LDL-cholesterol (Week 87)
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Assessment method [35]
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Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [35]
0
0
week -3, week 87
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Secondary outcome [36]
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Change in Triglycerides (Week 34)
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Assessment method [36]
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Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [36]
0
0
Week -3, week 34
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Secondary outcome [37]
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Change in Triglycerides (Week 87)
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Assessment method [37]
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Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [37]
0
0
week -3, week 87
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Secondary outcome [38]
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0
Change in Hs-CRP (Week 34)
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Assessment method [38]
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Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [38]
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0
Week -3, week 34
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Secondary outcome [39]
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Change in Hs-CRP (Week 87)
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Assessment method [39]
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Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [39]
0
0
week -3, week 87
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Secondary outcome [40]
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0
Change in IL-6 (Week 34)
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Assessment method [40]
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0
Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [40]
0
0
Week -3, week 34
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Secondary outcome [41]
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0
Change in IL-6 (Week 87)
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Assessment method [41]
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0
Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [41]
0
0
week -3, week 87
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Secondary outcome [42]
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0
Change in Body Weight (Week 34)
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Assessment method [42]
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Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [42]
0
0
Week -3, week 34
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Secondary outcome [43]
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0
Change in Body Weight (Week 87)
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Assessment method [43]
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0
Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [43]
0
0
week -3, week 87
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Secondary outcome [44]
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0
Change in Waist Circumference (Week 34)
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Assessment method [44]
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0
Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
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Timepoint [44]
0
0
Week -3, week 34
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Secondary outcome [45]
0
0
Change in Waist Circumference (Week 87)
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Assessment method [45]
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0
Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
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Timepoint [45]
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0
week -3, week 87
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Secondary outcome [46]
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0
Number of Adverse Events (Weeks 0-35)
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Assessment method [46]
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Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.
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Timepoint [46]
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0
Weeks 0-35
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Secondary outcome [47]
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0
Number of Adverse Events (Weeks 0-88)
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Assessment method [47]
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0
Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.
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Timepoint [47]
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0
Weeks 0-88
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Secondary outcome [48]
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0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
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Assessment method [48]
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0
Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
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Timepoint [48]
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0
Weeks 0 to 35
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Secondary outcome [49]
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0
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
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Assessment method [49]
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0
Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
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Timepoint [49]
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0
Weeks 0 to 88
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Secondary outcome [50]
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0
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
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Assessment method [50]
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0
Incidence of technical complaints were recorded from baseline (week 0) until week 35.
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Timepoint [50]
0
0
Weeks 0 to 35
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Secondary outcome [51]
0
0
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
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Assessment method [51]
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0
Incidence of technical complaints were recorded from baseline (week 0) until week 88.
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Timepoint [51]
0
0
Weeks 0 to 88
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Secondary outcome [52]
0
0
Change in Physical Examination During Exposure to Trial Product (Week 35)
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Assessment method [52]
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0
Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
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Timepoint [52]
0
0
Week 0 and week 35
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Secondary outcome [53]
0
0
Change in Physical Examination During Exposure to Trial Product (Week 88)
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Assessment method [53]
0
0
Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation
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Timepoint [53]
0
0
Week 0 and week 88
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Secondary outcome [54]
0
0
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
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Assessment method [54]
0
0
Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
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Timepoint [54]
0
0
Week -3 and week 35
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Secondary outcome [55]
0
0
Change in ECG Evaluation During Exposure to Trial Product (Week 88)
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Assessment method [55]
0
0
Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
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Timepoint [55]
0
0
Week -3 and week 88
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Secondary outcome [56]
0
0
Change in Diastolic Blood Pressure (Week 35)
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Assessment method [56]
0
0
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
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Timepoint [56]
0
0
Week -3, week 35
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Secondary outcome [57]
0
0
Change in Diastolic Blood Pressure (Week 88)
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Assessment method [57]
0
0
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
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Timepoint [57]
0
0
Week -3, week 88
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Secondary outcome [58]
0
0
Change in Systolic Blood Pressure (Week 35)
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Assessment method [58]
0
0
Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
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Timepoint [58]
0
0
Week -3, week 35
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Secondary outcome [59]
0
0
Change in Systolic Blood Pressure (Week 88)
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Assessment method [59]
0
0
Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
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Timepoint [59]
0
0
Week -3, week 88
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Secondary outcome [60]
0
0
Change in Pulse (Week 35)
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Assessment method [60]
0
0
Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Query!
Timepoint [60]
0
0
Week -3, week 35
Query!
Secondary outcome [61]
0
0
Change in Pulse (Week 88)
Query!
Assessment method [61]
0
0
Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Query!
Timepoint [61]
0
0
Week -3, week 88
Query!
Secondary outcome [62]
0
0
Change in Haemoglobin (Week 34)
Query!
Assessment method [62]
0
0
Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [62]
0
0
Week -3, week 34
Query!
Secondary outcome [63]
0
0
Change in Haemoglobin (Week 87)
Query!
Assessment method [63]
0
0
Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [63]
0
0
week -3, week 87
Query!
Secondary outcome [64]
0
0
Change in Haematocrit (Week 34)
Query!
Assessment method [64]
0
0
Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [64]
0
0
Week -3, week 34
Query!
Secondary outcome [65]
0
0
Change in Haematocrit (Week 87)
Query!
Assessment method [65]
0
0
Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [65]
0
0
week -3, week 87
Query!
Secondary outcome [66]
0
0
Change in Erythrocytes (Week 34)
Query!
Assessment method [66]
0
0
Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [66]
0
0
Week -3, week 34
Query!
Secondary outcome [67]
0
0
Change in Erythrocytes (Week 87)
Query!
Assessment method [67]
0
0
Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [67]
0
0
week -3, week 87
Query!
Secondary outcome [68]
0
0
Change in Mean Corpuscular Volume (MCV) (Week 34)
Query!
Assessment method [68]
0
0
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [68]
0
0
Week -3, week 34
Query!
Secondary outcome [69]
0
0
Change in Mean Corpuscular Volume (MCV) (Week 87)
Query!
Assessment method [69]
0
0
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [69]
0
0
week -3, week 87
Query!
Secondary outcome [70]
0
0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Query!
Assessment method [70]
0
0
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [70]
0
0
Week -3, week 34
Query!
Secondary outcome [71]
0
0
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Query!
Assessment method [71]
0
0
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [71]
0
0
week -3, week 87
Query!
Secondary outcome [72]
0
0
Change in Thrombocytes (Week 34)
Query!
Assessment method [72]
0
0
Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [72]
0
0
Week -3, week 34
Query!
Secondary outcome [73]
0
0
Change in Thrombocytes (Week 87)
Query!
Assessment method [73]
0
0
Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [73]
0
0
week -3, week 87
Query!
Secondary outcome [74]
0
0
Change in Leucocytes (Week 34)
Query!
Assessment method [74]
0
0
Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [74]
0
0
Week -3, week 34
Query!
Secondary outcome [75]
0
0
Change in Leucocytes (Week 87)
Query!
Assessment method [75]
0
0
Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [75]
0
0
week -3, week 87
Query!
Secondary outcome [76]
0
0
Change in Alanine Aminotransferase (ALT) (Week 34)
Query!
Assessment method [76]
0
0
Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [76]
0
0
Week -3, week 34
Query!
Secondary outcome [77]
0
0
Change in Alanine Aminotransferase (ALT) (Week 87)
Query!
Assessment method [77]
0
0
Change in ALT was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [77]
0
0
week -3, week 87
Query!
Secondary outcome [78]
0
0
Change in Albumin (Week 34)
Query!
Assessment method [78]
0
0
Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [78]
0
0
Week -3, week 34
Query!
Secondary outcome [79]
0
0
Change in Albumin (Week 87)
Query!
Assessment method [79]
0
0
Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [79]
0
0
week -3, week 87
Query!
Secondary outcome [80]
0
0
Change in Alkaline Phosphatase (ALP) (Week 34)
Query!
Assessment method [80]
0
0
Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [80]
0
0
Week -3, week 34
Query!
Secondary outcome [81]
0
0
Change in Alkaline Phosphatase (AP) (Week 87)
Query!
Assessment method [81]
0
0
Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [81]
0
0
Week -3, week 87
Query!
Secondary outcome [82]
0
0
Change in Aspartate Aminotransferase (AST) (Week 34)
Query!
Assessment method [82]
0
0
Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [82]
0
0
Week -3, week 34
Query!
Secondary outcome [83]
0
0
Change in Aspartate Aminotransferase (AST) (Week 87)
Query!
Assessment method [83]
0
0
Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [83]
0
0
Week -3, week 87
Query!
Secondary outcome [84]
0
0
Change in Bilirubin (Week 34)
Query!
Assessment method [84]
0
0
Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [84]
0
0
Week -3, week 34
Query!
Secondary outcome [85]
0
0
Change in Bilirubin (Week 87)
Query!
Assessment method [85]
0
0
Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [85]
0
0
week -3, week 87
Query!
Secondary outcome [86]
0
0
Change in Calcium (Week 34)
Query!
Assessment method [86]
0
0
Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [86]
0
0
Week -3, week 34
Query!
Secondary outcome [87]
0
0
Change in Calcium (Week 87)
Query!
Assessment method [87]
0
0
Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [87]
0
0
week -3, week 87
Query!
Secondary outcome [88]
0
0
Change in Chloride (Week 34)
Query!
Assessment method [88]
0
0
Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [88]
0
0
Week -3, week 34
Query!
Secondary outcome [89]
0
0
Change in Chloride (Week 87)
Query!
Assessment method [89]
0
0
Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [89]
0
0
week -3, week 87
Query!
Secondary outcome [90]
0
0
Change in Creatinine (Week 34)
Query!
Assessment method [90]
0
0
Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [90]
0
0
Week -3, week 34
Query!
Secondary outcome [91]
0
0
Change in Creatinine (Week 87)
Query!
Assessment method [91]
0
0
Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [91]
0
0
week -3, week 87
Query!
Secondary outcome [92]
0
0
Change in Creatine Kinase (Week 34)
Query!
Assessment method [92]
0
0
Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [92]
0
0
Week -3, week 34
Query!
Secondary outcome [93]
0
0
Change in Creatine Kinase (Week 87)
Query!
Assessment method [93]
0
0
Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [93]
0
0
week -3, week 87
Query!
Secondary outcome [94]
0
0
Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Query!
Assessment method [94]
0
0
Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [94]
0
0
Week -3, week 34
Query!
Secondary outcome [95]
0
0
Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Query!
Assessment method [95]
0
0
Change in GGT was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [95]
0
0
week -3, week 87
Query!
Secondary outcome [96]
0
0
Change in Phosphate (Inorganic) (Week 34)
Query!
Assessment method [96]
0
0
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [96]
0
0
Week -3, week 34
Query!
Secondary outcome [97]
0
0
Change in Phosphate (Inorganic)(Week 87)
Query!
Assessment method [97]
0
0
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [97]
0
0
week -3, week 87
Query!
Secondary outcome [98]
0
0
Change in Potassium (Week 34)
Query!
Assessment method [98]
0
0
Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [98]
0
0
Week -3, week 34
Query!
Secondary outcome [99]
0
0
Change in Potassium (Week 87)
Query!
Assessment method [99]
0
0
Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [99]
0
0
week -3, week 87
Query!
Secondary outcome [100]
0
0
Change in Sodium (Week 34)
Query!
Assessment method [100]
0
0
Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [100]
0
0
Week -3, week 34
Query!
Secondary outcome [101]
0
0
Change in Sodium (Week 87)
Query!
Assessment method [101]
0
0
Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [101]
0
0
week -3, week 87
Query!
Secondary outcome [102]
0
0
Change in Total Protein (Week 34)
Query!
Assessment method [102]
0
0
Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [102]
0
0
Week -3, week 34
Query!
Secondary outcome [103]
0
0
Change in Total Protein (Week 87)
Query!
Assessment method [103]
0
0
Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Query!
Timepoint [103]
0
0
week -3, week 87
Query!
Secondary outcome [104]
0
0
Change in Urea (Week 34)
Query!
Assessment method [104]
0
0
Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [104]
0
0
Week -3, week 34
Query!
Secondary outcome [105]
0
0
Change in Urea (Week 87)
Query!
Assessment method [105]
0
0
Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [105]
0
0
week -3, week 87
Query!
Secondary outcome [106]
0
0
Change in Uric Acid (Week 34)
Query!
Assessment method [106]
0
0
Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [106]
0
0
Week -3, week 34
Query!
Secondary outcome [107]
0
0
Change in Uric Acid (Week 87)
Query!
Assessment method [107]
0
0
Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [107]
0
0
week -3, week 87
Query!
Secondary outcome [108]
0
0
Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
Query!
Assessment method [108]
0
0
Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [108]
0
0
Week -3, week 34
Query!
Secondary outcome [109]
0
0
Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Query!
Assessment method [109]
0
0
Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [109]
0
0
week -3, week 87
Query!
Secondary outcome [110]
0
0
Change in Fasting Plasma Glucose (Week 34)
Query!
Assessment method [110]
0
0
Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [110]
0
0
Week -3, week 34
Query!
Secondary outcome [111]
0
0
Change in Fasting Plasma Glucose (Week 87)
Query!
Assessment method [111]
0
0
Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [111]
0
0
week -3, week 87
Query!
Secondary outcome [112]
0
0
Change in Fasting Insulin (Week 34)
Query!
Assessment method [112]
0
0
Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [112]
0
0
Week -3, week 34
Query!
Secondary outcome [113]
0
0
Change in Fasting Insulin (Week 87)
Query!
Assessment method [113]
0
0
Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [113]
0
0
week -3, week 87
Query!
Secondary outcome [114]
0
0
Change in Steady State Beta Cell Function (%B) (Week 34)
Query!
Assessment method [114]
0
0
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [114]
0
0
Week -3, week 34
Query!
Secondary outcome [115]
0
0
Change in Steady State Beta Cell Function (%B) (Week 87)
Query!
Assessment method [115]
0
0
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Query!
Timepoint [115]
0
0
week -3, week 87
Query!
Secondary outcome [116]
0
0
Change in Insulin Resistance (IR %) (Week 34)
Query!
Assessment method [116]
0
0
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [116]
0
0
Week -3, week 34
Query!
Secondary outcome [117]
0
0
Change in Insulin Resistance (IR %) (Week 87)
Query!
Assessment method [117]
0
0
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [117]
0
0
week -3, week 87
Query!
Secondary outcome [118]
0
0
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Query!
Assessment method [118]
0
0
Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Query!
Timepoint [118]
0
0
Week -3, week 34
Query!
Secondary outcome [119]
0
0
Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
Query!
Assessment method [119]
0
0
Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Query!
Timepoint [119]
0
0
week -3, week 87
Query!
Eligibility
Key inclusion criteria
- Male or female of at least 23 years of age and not more than 79 years of age at the
time of signing informed consent
- Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone
(GH) secretagogues for at least 180 days prior to randomisation with any registered or
investigational hGH or GH secretagogue product (if only used in connection with
stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be
included)
- If applicable, hormone replacement therapies for any other hormone deficiencies,
adequate and stable for at least 90 days prior to randomisation as judged by the
investigator
- FOR ALL COUNTRIES EXCEPT JAPAN:
Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the
following criterion and documentation of test results must be available before
randomisation (either from subjects' file or new test):
1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL
(3 mcg/L)
2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index
(BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI
25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2,
a peak GH less than 4 ng/mL (4 mcg/L)
3. Three or more pituitary hormone deficiencies and insulin like growth factor - I
standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed
diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth
hormone deficiency (AGHD) need to satisfy at least one of the following criteria,
subjects with a history of childhood GHD need to satisfy at least 2 of the following
criteria):
a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH
standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using
recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a
peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)
Query!
Minimum age
23
Years
Query!
Query!
Maximum age
79
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Active malignant disease or history of malignancy. Exceptions to this exclusion
criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of
squamous cell or basal cell carcinoma of the skin
- Subjects with GHD attributed to treatment of intracranial malignant tumours or
leukaemia, provided that a recurrence-free survival period of at least 5 years is
documented in the subject's file
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
31/10/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
7/05/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
301
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Novo Nordisk Investigational Site - Blacktown
Query!
Recruitment hospital [2]
0
0
Novo Nordisk Investigational Site - Coffs Harbour
Query!
Recruitment hospital [3]
0
0
Novo Nordisk Investigational Site - Darlinghurst
Query!
Recruitment hospital [4]
0
0
Novo Nordisk Investigational Site - St Leonards
Query!
Recruitment hospital [5]
0
0
Novo Nordisk Investigational Site - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Novo Nordisk Investigational Site - Box Hill
Query!
Recruitment hospital [7]
0
0
Novo Nordisk Investigational Site - Parkville
Query!
Recruitment hospital [8]
0
0
Novo Nordisk Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2148 - Blacktown
Query!
Recruitment postcode(s) [2]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [3]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [4]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [6]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [7]
0
0
3052 - Parkville
Query!
Recruitment postcode(s) [8]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Missouri
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nevada
Query!
Country [12]
0
0
United States of America
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Ohio
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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Brazil
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Sao Paulo
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Germany
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Germany
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Frankfurt
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Germany
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Oldenburg
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India
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Andhra Pradesh
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India
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India
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Kerala
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India
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Maharashtra
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India
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New Delhi
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India
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Punjab
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India
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Telengana
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India
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West Bengal
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Israel
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Bunkyo-ku, Tokyo
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Japan
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Chiba-shi, Chiba
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Japan
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Fukuoka-shi, Fukuoka
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Japan
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Hamamatsu-shi, Shizuoka
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Japan
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Itabashi-ku, Tokyo
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Japan
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Kagoshima
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Japan
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Kyoto-shi Kyoto
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Japan
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Minato-ku, Tokyo
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Japan
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Okayama, Okayama
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Japan
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Sagamihara-shi, Kanagawa
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Japan
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Sapporo, Hokkaido
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Japan
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Sappro-shi, Hokkaido
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Japan
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Tokyo
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Japan
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Yamagata-shi, Yamagata
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Japan
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Yokohama, Kanagawa
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Latvia
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Riga
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Kaunas
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Vilnius
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Kuching
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Pulau Pinang
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Malaysia
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Putrajaya
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Norway
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Oslo
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Poland
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Bialystok
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Cluj
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Romania
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Mures
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Romania
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Bucuresti
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Romania
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Iasi
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Country [66]
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Romania
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Sibiu
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Timisoara
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Russian Federation
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Kazan
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Tomsk
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South Africa
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Gauteng
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South Africa
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Western Cape
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Sweden
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Göteborg
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Stockholm
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Sweden
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Uppsala
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Turkey
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Adana
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Turkey
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Istanbul
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Turkey
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Izmir
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Kocaeli
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Ukraine
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Kyiv
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Birmingham
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Exeter
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Hull
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Leeds
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London
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novo Nordisk A/S
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Ethics approval
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Summary
Brief summary
This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly
dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin
(human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone
deficiency.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02229851
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Reporting Anchor and Disclosure' (1452)
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Address
0
0
Novo Nordisk A/S
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02229851
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