Acromegaly
Conditions
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.
Interventions
DRUGPegvisomant
DRUGSandostatin LAR
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom, United States
Outcome results
None listed