Pegvisomant And Sandostatin LAR Combination Study
A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly
2 other identifiers
interventional
75
12 countries
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2003
Typical duration for phase_4
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2003
CompletedFirst Posted
Study publicly available on registry
September 5, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedApril 7, 2008
April 1, 2008
September 4, 2003
April 3, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects experiencing treatment-emergent adverse events across the duration fo the study
Secondary Outcomes (1)
Percentage of patients with normalization of IGF-I, at Week 40, in the two randomized groups (Sandostatin LAR plus pegvisomant and pegvisomant alone). Normal IGF-I is defined as a value within the normal reference range for age for the study specific
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (33)
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Boston, Massachusetts, 02114, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600, United States
Pfizer Investigational Site
Charlottesville, Virginia, 22908, United States
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010, Australia
Pfizer Investigational Site
Fitzroy, Victoria, 3165, Australia
Pfizer Investigational Site
Fizroy, Victoria, 3165, Australia
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, 05403-060, Brazil
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
Pfizer Investigational Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5, Canada
Pfizer Investigational Site
Montpellier, 34295, France
Pfizer Investigational Site
Nice, 06202, France
Pfizer Investigational Site
Berlin, 10117, Germany
Pfizer Investigational Site
Dresden, 01307, Germany
Pfizer Investigational Site
Hanover, Germany
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Messina, 98122, Italy
Pfizer Investigational Site
Milan, 20162, Italy
Pfizer Investigational Site
Torino, Italy
Pfizer Investigational Site
Mexico City, Mexico City, 06720, Mexico
Pfizer Investigational Site
Col La Raza, Mexico DF, 02990, Mexico
Pfizer Investigational Site
Nijmegen, 6500 GA, Netherlands
Pfizer Investigational Site
Oslo, 0027, Norway
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Pfizer Investigational Site
Madrid, Madrid, 28035, Spain
Pfizer Investigational Site
Belfast, Antrim, BT12 6BA, United Kingdom
Pfizer Investigational Site
Leeds, LS1 3EX, United Kingdom
Pfizer Investigational Site
London, EC1A 7BE, United Kingdom
Pfizer Investigational Site
London, SE1 7EH, United Kingdom
Pfizer Investigational Site
Manchester, M20 4BX, United Kingdom
Pfizer Investigational Site
Oxford, OX3 7LJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 4, 2003
First Posted
September 5, 2003
Study Start
October 1, 2003
Study Completion
May 1, 2006
Last Updated
April 7, 2008
Record last verified: 2008-04