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

April 3, 2008 updated by: Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • Pfizer Investigational Site
    • Victoria
      • Fitzroy, Victoria, Australia, 3165
        • Pfizer Investigational Site
      • Heidelberg, Victoria, Australia, 3084
        • Pfizer Investigational Site
  • Brazil
    • PR
      • Curitiba, PR, Brazil, 80030-110
        • Pfizer Investigational Site
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-590
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Pfizer Investigational Site
    • SP
      • Sao Paulo, SP, Brazil, 05403-060
        • Pfizer Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2L 2W5
        • Pfizer Investigational Site
  • France
      • Le Kremlin Bicetre, France, 94275
        • Pfizer Investigational Site
      • Pessac, France, 33604
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Dresden, Germany, 01307
        • Pfizer Investigational Site
      • Essen, Germany, 45147
        • Pfizer Investigational Site
      • Hamburg, Germany, 22767
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69120
        • Pfizer Investigational Site
      • Marburg, Germany, 35043
        • Pfizer Investigational Site
  • Greece
      • Piraeus, Greece, 18537
        • Pfizer Investigational Site
    • Attika/Greece
      • Athens, Attika/Greece, Greece, 10676
        • Pfizer Investigational Site
  • Ireland
      • Cork, Ireland
        • Pfizer Investigational Site
      • Dublin 9, Ireland
        • Pfizer Investigational Site
  • Italy
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Milano, Italy, 20122
        • Pfizer Investigational Site
      • Napoli, Italy
        • Pfizer Investigational Site
      • Roma, Italy, 00168
        • Pfizer Investigational Site
      • Torino, Italy
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28035
        • Pfizer Investigational Site
      • Sevilla, Spain, 41013
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
      • Hospitalet de Llobregat, Barcelona, Spain, 08906
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Linkoping, Sweden, 581 85
        • Pfizer Investigational Site
      • Stockholm, Sweden, 171 76
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • Pfizer Investigational Site
      • London, United Kingdom, EC1A 7BE
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 7EH
        • Pfizer Investigational Site
    • Ireland
      • Belfast, Ireland, United Kingdom, BT12 6BA
        • Pfizer Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
      • Chicago, Illinois, United States
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0030
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48109-0108
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 4, 2003

First Submitted That Met QC Criteria

September 5, 2003

First Posted (Estimate)

September 8, 2003

Study Record Updates

Last Update Posted (Estimate)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGA-0435-003
  • A6291004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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