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

Tracking Information

First Received Date ^ICMJE

September 4, 2003

Last Updated Date

April 3, 2008

Start Date ^ICMJE

April 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00068042 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 Visi

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Drug: Pegvisomant
Drug: Sandostatin LAR

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Brazil, Canada, France, Germany, Greece, Ireland, Italy, Norway, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00068042

Responsible Party

Study ID Numbers ^ICMJE

PEGA-0435-003, A6291004

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP