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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Octreotide

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