Brief Title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Official Title
A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
Secondary Outcome
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
Condition
Acromegaly
Intervention
Pegvisomant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
April 2003
Completion Date
May 2006
Eligibility Criteria
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 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00068042
Organization ID
PEGA-0435-003
Secondary IDs
A6291004
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
April 2008