Pegvisomant And Sandostatin LAR Combination Study

Pfizer

Status and phase

Completed

Phase 4

Conditions

Acromegaly

Treatments

Drug: Pegvisomant

Drug: Sandostatin LAR

Drug: Pegvisomant/ Sandostatin LAR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00068029

A6291006

PEGA-0435-005

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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