NCT00068029CompletedPhase 4
A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 75
- Locations
- 34
- Primary Endpoint
- Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Study Overview
Brief Summary
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of acromegaly
- •Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
- •Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment
Exclusion Criteria
- •Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or IGF-I concentrations
- •Patients on current medical therapy other than Sandostatin LAR
- •AST/ALT >= 3xULN (upper limits 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
- •Radiotherapy within 12 months of entering the study
Outcomes
Primary Outcomes
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary Outcomes
- Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific
Investigators
Study Sites (34)
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