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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/NCT01915303
Registration number
NCT01915303
Ethics application status
Date submitted
10/06/2013
Date registered
2/08/2013
Date last updated
18/09/2020
Titles & IDs
Public title
Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease
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Scientific title
A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease
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Secondary ID [1]
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CSOM230B2411
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cushings Disease
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Condition category
Condition code
Metabolic and Endocrine
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Other endocrine disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pasireotide with or without cabergoline
Experimental: pasireotide +/- cabergoline - pasireotide alone or with cabergoline
Treatment: Drugs: Pasireotide with or without cabergoline
The trial consisted of Pasireotide-untreated patients who started pasireotide 0.6mg twice a day for 8 weeks. If biochemical control was not achieved by the end of the 8 weeks, and the 0.6mg dose is well-tolerated, the dose was increased to 0.9mg twice a day for another 8 weeks. If biochemical control is not achieved, cabergoline was added and patients began combination treatment with cabergoline at the starting dose of 0.5mg once a day for 8 weeks. If biochemical control is still not achieved at the end of the third 8 week period, the dose of cabergoline was increased to 1.0mg once a day. Patients could also immediately start the combination treatment by adding cabergoline 0.5mg once a day at study entry to their current maximal tolerated dose of pasireotide. Patients continued with the combination treatment for 8 weeks. If biochemical control was not not achieved by the end of the 8 week period, the dose of cabergoline was increased to 1mg once a day.
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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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Percentage of Responders With Mean Urinary Free Cortisol (mUFC) = 1.0xULN Collected or Imputed at Week 35
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Assessment method [1]
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Participants who attained mUFC = 1.0 x ULN (upper limit of normal) with pasireotide alone or in combination with cabergoline. The 24h-UFC concentration results from three samples, collected during the screening period, were averaged to obtain the Baseline urinary free cortisol level. mean 24h-UFC was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit. Imputation: subjects who completed the end of treatment visit at Week 35, but had missing evaluation of mean urinary free cortisol (mUFC). The last available mUFC assessment at or after previous visit (week) before last week was carried forward as the last week mUFC assessment.
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Timepoint [1]
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Baseline up to week 35
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Secondary outcome [1]
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Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
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Assessment method [1]
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Mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
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Timepoint [1]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
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Secondary outcome [2]
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Percentage of Responders With Mean Urinary Free Cortisol (mUFC) = 1.0xULN
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Assessment method [2]
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Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
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Timepoint [2]
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Baseline up to week 235
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Secondary outcome [3]
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Percentage of Participants Who Attain mUFC = 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
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Assessment method [3]
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Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
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Timepoint [3]
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Baseline up to week 235
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Secondary outcome [4]
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Duration (Weeks) of Controlled or Partially Controlled Response
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Assessment method [4]
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Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC = 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC > 1.0 x ULN and the reduction from baseline falls to less than 50% from the first time
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Timepoint [4]
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from the date patient's first normalization (mUFC = 1.0xULN) or at least 50% reduction from baseline up to the date when the patient's mUFC > 1.0 x ULN
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Secondary outcome [5]
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Plasma Adrenocorticotropic Hormone (ACTH)
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Assessment method [5]
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A pre-dose blood draw for plasma ACTH sampling was taken at visits. Samples were analyzed by a central laboratory.
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Timepoint [5]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
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Secondary outcome [6]
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Serum Cortisol Levels
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Assessment method [6]
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A pre-dose blood draw for an 8 am fasting serum cortisol measurement were taken at visits. Samples were analyzed by a central laboratory.
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Timepoint [6]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
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Secondary outcome [7]
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Sitting Systolic Blood Pressure at Week 35
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Assessment method [7]
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The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
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Timepoint [7]
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Baseline and week 35
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Secondary outcome [8]
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Sitting Diastolic Blood Pressure at Week 35
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Assessment method [8]
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The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
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Timepoint [8]
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Baseline and week 35
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Secondary outcome [9]
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Body Weight at Week 35
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Assessment method [9]
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Weight was was one of the measures of clinical symptoms of CD
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Timepoint [9]
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Baseline and week 35
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Secondary outcome [10]
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Body Mass Index at Week 35
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Assessment method [10]
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Body mass index was one of the measurements of clinical symptoms of CD. Body mass index=weight in kg divided by the square of the body height (in meters)
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Timepoint [10]
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Baseline and week 35
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Secondary outcome [11]
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Waist Circumference at Week 35
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Assessment method [11]
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Waist circumference was one of the measurements of clinical signs of CD
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Timepoint [11]
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Baseline and week 35
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Secondary outcome [12]
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LDL, HDL and Total Cholesterol at Week 35
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Assessment method [12]
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LDL=Low density lipoprotein, HDL=high density llipoprotein and total protein were analyzed by a central laboratory
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Timepoint [12]
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Baseline and week 35
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Secondary outcome [13]
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Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
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Assessment method [13]
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Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100* (X - n) / n*5 - n*1) = 100 * (X - n) / 4*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0
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Timepoint [13]
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Baseline and week 17 and 35
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Secondary outcome [14]
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Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
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Assessment method [14]
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SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.
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Timepoint [14]
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Baseline, week 17 and 35
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Secondary outcome [15]
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Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
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Assessment method [15]
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Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [15]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
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Secondary outcome [16]
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Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
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Assessment method [16]
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Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [16]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
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Secondary outcome [17]
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Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
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Assessment method [17]
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Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [17]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
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Secondary outcome [18]
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Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
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Assessment method [18]
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Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [18]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
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Secondary outcome [19]
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Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
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Assessment method [19]
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Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [19]
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Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
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Secondary outcome [20]
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Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
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Assessment method [20]
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Facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad were assessed. Two photographs, one frontal and one lateral from the shoulders up will be taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position will be taken to assess striae, and hirsutism. The photographs must be assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
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Timepoint [20]
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Baseline, weeks 1, 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension
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Secondary outcome [21]
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Number of Patients With Shift From Standing Easily to Not Being Able to Stand
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Assessment method [21]
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To test proximal muscle strength patients should be placed in a low seated position (for instance on an examination room stool). They should be asked to extend the arms in front of them. From this seated position patients will be asked to stand up. Patients will be evaluated using the following scale: 3. - completely unable to stand 2. - able to stand only by using arms as assistance
1. - able to stand after several efforts without using arms as assistance 0. - able to stand easily with arms extended
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Timepoint [21]
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Baseline up to week 267
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Written informed consent obtained prior to screening procedures
2. Adult patients with confirmed diagnosis of ACTH-dependent Cushing's disease as
evidenced by all of the following:
1. The mean of three 24-hour urine samples collected within 2 weeks > 1xULN with 2
out of 3 samples >ULN
2. Morning plasma ACTH within the normal or above normal range
3. Either MRI confirmation of pituitary adenoma > 6 mm, or inferior petrosal sinus
gradient >3 after CRH stimulation for those patients with a tumor less than or
equal to 6 mm*. For patients who have had prior pituitary surgery, histopathology
confirming an ACTH staining adenoma *If IPSS had previously been performed
without CRH (e.g. with DDAVP), then a central to peripheral pre-stimulation
gradient > 2 was required. If IPSS had not previously been performed, IPSS with
CRH stimulation was required.
3. Patients with de novo Cushing's disease could only be included only if they were not
considered candidates for pituitary surgery (e.g. poor surgical candidates, surgically
unapproachable tumors, patients who refused to have surgical treatment)
4. Male or female patients aged 18 years or greater
5. Karnofsky performance status = 60 (i.e. required occasional assistance, but was able
to care for most of their personal needs)
6. Patients on medical treatment for Cushing's disease the following washout periods must
have been completed before screening assessments were performed
- Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
- Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and
PPAR? agonists (rosiglitazone or pioglitazone): 4 weeks
- Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
- Octreotide (immediate release formulation): 1 week
- Progesterone receptor antagonist (mifepristone): 4 weeks
7. Patients could have been considered to enter the trial if they met any one of the
following criteria: 1) They were naive to pasireotide 2) They had received pasireotide
in the past and have been discontinued because of lack of efficacy (2 weeks for
washout prior to screening for patients treated with pasireotide subcutaneously and 12
weeks of washout prior to screening for patients treated with pasireotide LAR) 3)
Patients who were on maximal tolerated dose but had not achieved biochemical control
8. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, if they were using highly effective methods of contraception during
dosing and for 30 days after stopping study medication.
9. Male participants in the trial must have agreed to use a condom during intercourse,
and not to father a child during the study and for the period of 30 days following
stopping of the study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Patients with compression of the optic chiasm that caused any visual field defect that
required surgical intervention
2. Diabetic patients with poor glycemic control as evidenced by HbA1c >8%
3. Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF
>450 ms in males, and > 460 ms in females. hypokalemia, hypomagnesaemia, uncontrolled
hypothyroidism, family history of long QT syndrome, or concomitant medications known
to prolong QT interval.
4. Patients with clinically significant valvular disease.
5. Patients with Cushing's syndrome due to ectopic ACTH secretion
6. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary)
bilateral adrenal hyperplasia
7. Patients who had congestive heart failure (NYHA Class III or IV), unstable angina,
sustained ventricular tachycardia, clinically significant bradycardia, advanced heart
block, history of acute MI less than one year prior to study entry or clinically
significant impairment in cardiovascular function
8. Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic
persistent hepatitis, or patients with ALT/AST > 2 X ULN, serum bilirubin >2.0 X ULN
9. Patients with serum creatinine >2.0 X ULN
10. Patients with WBC <3 X 10e9/L; Hb 90% < LLN; PLT <100 X 10e9/L
11. Patients with presence of Hepatitis B surface antigen (HbsAg)
12. Patients with presence of Hepatitis C antibody test (anti-HCV)
13. Patients with severe hepatic impairment (Child Pugh C) and hypersensitivity to
pasireotide or cabergoline
14. Patients with lung, pericardial, and retroperitoneal fibrosis; gastro-duodenal ulcer
or digestive haemorrhage, galactose intolerance, Parkinson's disease, uncontrolled
hypertension and Raynauds syndrome.
15. Pregnant or nursing (lactating) women where pregnancy was defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5 mIU/ml)
16. Patients with end-stage renal failure and/or hemodialysis
17. Patients with presence of active or suspected acute or chronic uncontrolled infection
18. Patients with a history of non-complance to medical regimens or who were considered
potentially unreliable or were unable to complete the entire study
19. Patients with presence of Hepatitis B surface antigen (HbsAg)
20. Patients with presence of Hepatitis C antibody test (anti-HCV)
21. Patients with severe hepatic impairment (Child Pugh C) and hpersensitivity to
pasireotide or cabergoline
22. Patients with lung, pericardial, and retroperitoneal fibrosis; gastroduodenal ulcer or
digestive haemorrhage, galactose intolerance, Parkinson's disease, uncontrolled
hypertension and Raynaud's syndrome
23. Pregnant or nursing (lactating) women where pregnancy was defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5mIU/mL)
24. Patients with end-stage renal failure and/or hemodialysis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/09/2019
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Sample size
Target
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Accrual to date
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Final
68
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Oregon
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Country [3]
0
0
Argentina
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State/province [3]
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Buenos Aires
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Country [4]
0
0
Belgium
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State/province [4]
0
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Gent
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Country [5]
0
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Belgium
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State/province [5]
0
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Leuven
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0
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Brazil
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State/province [6]
0
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PR
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Country [7]
0
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Brazil
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State/province [7]
0
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RJ
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Country [8]
0
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Brazil
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State/province [8]
0
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RS
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Country [9]
0
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Brazil
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State/province [9]
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SP
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Country [10]
0
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Colombia
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State/province [10]
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0
Cundinamarca
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Country [11]
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0
France
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State/province [11]
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Vandoeuvre Cedex
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Country [12]
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Germany
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State/province [12]
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Erlangen
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0
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Greece
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State/province [13]
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Athens
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Greece
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State/province [14]
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Thessaloniki
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Country [15]
0
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Hungary
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State/province [15]
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Budapest
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Country [16]
0
0
India
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State/province [16]
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0
Tamil Nadu
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Country [17]
0
0
India
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State/province [17]
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Chandigarh
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Country [18]
0
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India
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State/province [18]
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New Delhi
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Country [19]
0
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Italy
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State/province [19]
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Napoli
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Country [20]
0
0
Malaysia
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State/province [20]
0
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Wilayah Persekutuan
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Country [21]
0
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Mexico
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State/province [21]
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Distrito Federal
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Country [22]
0
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Mexico
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State/province [22]
0
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Durango
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Country [23]
0
0
Netherlands
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State/province [23]
0
0
Rotterdam
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Country [24]
0
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Spain
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State/province [24]
0
0
Andalucia
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Country [25]
0
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Spain
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State/province [25]
0
0
Comunidad Valenciana
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Country [26]
0
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Turkey
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State/province [26]
0
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TUR
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Country [27]
0
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Turkey
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State/province [27]
0
0
Izmir
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Country [28]
0
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Turkey
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State/province [28]
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Pendik / Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate
the efficacy and safety of pasireotide alone or in combination with cabergoline in patients
with Cushing's disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01915303
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
0
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Fax
0
0
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Email
0
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Contact person for public queries
Name
0
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Address
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Country
0
0
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01915303
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