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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Darlinghurst, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegvisomant

Drug

Sandostatin LAR

Drug

Primary outcomes

Percentage of patients with normal IGF-1 concentration at Final Visit (Week 52)

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start: 2003
Study completion: 2006
First posted: Sep 8, 2003
Registry last updated: Apr 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed