- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367783
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
July 29, 2011 updated by: Pfizer
A 12-Week, Phase 2A, Randomized, Subject And Investigator Blind, Placebo-Controlled Trial To Evaluate The Effect Of CP-741,952 On Weight Loss In Otherwise Healthy Overweight And Obese Adult Subjects
The purpose of this study is to determine whether CP-741,952 is effective in the treatment of obesity and to determine 12 week safety and toleration.
Study Overview
Detailed Description
Following review of the preliminary data from completed study A7081004, the development program for CP-741,952 was terminated on 15 March 2007.
Primary reasons for program termination included a lack of significant efficacy at all doses investigated and an increased incidence of mild to moderate elevations in serum transaminases, primarily alanine aminotransferase (ALT), and liver fat content, in treated compared to placebo subjects.
A synopsis will be created and will include greater detail on these findings.
Study Type
Interventional
Enrollment
100
Phase
- Phase 2
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
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Michigan
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Ann Arbor, Michigan, United States, 48105
- Pfizer Investigational Site
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Kalamazoo, Michigan, United States, 49007
- Pfizer Investigational Site
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New York
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New York, New York, United States, 10021-7903
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28211
- Pfizer Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI of 30-40 kg/m2
Exclusion Criteria:
- Women of childbearing potential
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: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Weight Loss, toleration, safety
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Secondary Outcome Measures
Outcome Measure |
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Waist Circumference, serum lipids
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
June 1, 2006
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
May 30, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 23, 2006
Study Record Updates
Last Update Posted (Estimate)
August 1, 2011
Last Update Submitted That Met QC Criteria
July 29, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7081004
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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