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Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

Primary Purpose

Obesity

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CP-741,952
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI of 30-40 kg/m2 Exclusion Criteria: Women of childbearing potential

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

Weight Loss, toleration, safety

Secondary Outcome Measures

Waist Circumference, serum lipids

Full Information

First Posted
May 30, 2006
Last Updated
July 29, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00367783
Brief Title
Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description for termination reason.
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CP-741,952
Primary Outcome Measure Information:
Title
Weight Loss, toleration, safety
Secondary Outcome Measure Information:
Title
Waist Circumference, serum lipids

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI of 30-40 kg/m2 Exclusion Criteria: Women of childbearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021-7903
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7081004&StudyName=Safety%2C%20Toleration%20and%20Efficacy%20of%20CP-741%2C952%20for%20the%20Treatment%20of%20Obesity
Description
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Safety, Toleration and Efficacy of CP-741,952 for the Treatment of Obesity

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