A Study To Compare The Efficacy And Safety Of Pegvisomant To That Of Sandostatin Lar Depot In Patients With Acromegaly

Pfizer

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Sandostatin LAR; Drug: Pegvisomant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00068042

A6291004

PEGA-0435-003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)