A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly
Phase 4
Completed
- Conditions
- Acromegaly
- Registration Number
- NCT00068042
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧London, United Kingdom