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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/NCT00068042




Registration number
NCT00068042
Ethics application status
Date submitted
4/09/2003
Date registered
8/09/2003
Date last updated
7/04/2008

Titles & IDs
Public title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Scientific title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Secondary ID [1] 0 0
A6291004
Secondary ID [2] 0 0
PEGA-0435-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pegvisomant
Treatment: Drugs - Sandostatin LAR

Treatment: Drugs: Pegvisomant


Treatment: Drugs: Sandostatin LAR
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Timepoint [1] 0 0
Secondary outcome [1] 0 0
The secondary endpoints include: 1.Percentage of patients with normal IGF-I concentration at any visit. 2.Percent change from Baseline of IGF-I at each visit. 3.Percent change from Baseline of IGFBP-3 (IGF binding protein-3) at Week 24 and Final Visit
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Diagnosis of acromegaly

- IGF-I levels >=1.3xULN (upper limit of normal) at screening

- No history of radiotherapy or prior treatment with other drugs for acromegaly

- Minimum of two months must have elapsed post surgery prior to screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or
IGF-I concentrations

- AST/ALT >= 3xULN (upper limit of normal)

- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI

- Visual field defects (except post surgical stable residual defects)

- Unable to self administer drug

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Fitzroy
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3165 - Fitzroy
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment outside Australia
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United States of America
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California
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United States of America
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Illinois
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United States of America
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Massachusetts
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Michigan
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New York
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North Carolina
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United States of America
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Ohio
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Virginia
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Brazil
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PR
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Brazil
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RJ
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Brazil
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RS
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Brazil
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SP
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Quebec
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France
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Le Kremlin Bicetre
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France
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Pessac
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Marburg
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Greece
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Attika/Greece
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Greece
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Piraeus
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Ireland
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Cork
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Ireland
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Dublin 9
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Italy
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Genova
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Italy
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Milano
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Italy
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Napoli
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Italy
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Roma
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Italy
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Torino
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Norway
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Oslo
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Sweden
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Goteborg
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Sweden
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Linkoping
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Sweden
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Ireland
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United Kingdom
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Leeds
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine if Pegvisomant is more efficacious than Sandostatin
LAR Depot in normalizing IGF-I levels in treatment naive patients with acromegaly.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00068042
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00068042