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NCT00375401 Clinical Trial

A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

Obesity Clinical Trial

Official title:
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00375401
Other study ID # A5351025
Secondary ID
Status Terminated
Phase Phase 3
First received September 11, 2006
Last updated November 5, 2012
Start date October 2006
Est. completion date January 2009

Study information
Verified date November 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Description:

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Recruitment information / eligibility
Status Terminated
Enrollment 2536
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia

Exclusion Criteria:

- Pregnancy

- Diabetes

- Adults with serious or unstable current or past medical conditions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• CP-945,598 Treatment A
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
• CP-945,598 Treatment B
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
• Placebo
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling

Locations
Country Name City State
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Charlottetown Prince Edward Island
Canada Pfizer Investigational Site Hamilton Ontario
Canada Pfizer Investigational Site L'Ancienne-Lorette Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Oakville Ontario
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
United States Pfizer Investigational Site Akron Ohio
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Baton Rouge Louisiana
United States Pfizer Investigational Site Beaumont Texas
United States Pfizer Investigational Site Beaver Pennsylvania
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bristol Tennessee
United States Pfizer Investigational Site Burlington North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Charlottesville Virginia
United States Pfizer Investigational Site Chaska Minnesota
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cumberland Rhode Island
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Edina Minnesota
United States Pfizer Investigational Site Endwell New York
United States Pfizer Investigational Site Fairhope Alabama
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Greer South Carolina
United States Pfizer Investigational Site Gurnee Illinois
United States Pfizer Investigational Site Hamilton New Jersey
United States Pfizer Investigational Site Honolulu Hawaii
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Kingsport Tennessee
United States Pfizer Investigational Site Kingston New York
United States Pfizer Investigational Site Knoxville Tennessee
United States Pfizer Investigational Site La Jolla California
United States Pfizer Investigational Site Lake Jackson Texas
United States Pfizer Investigational Site Lexington Kentucky
United States Pfizer Investigational Site Longmont Colorado
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Manlius New York
United States Pfizer Investigational Site Medford Oregon
United States Pfizer Investigational Site Milford Massachusetts
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Morgantown West Virginia
United States Pfizer Investigational Site Mount Pleasant South Carolina
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Norfolk Virginia
United States Pfizer Investigational Site North Dartmouth Massachusetts
United States Pfizer Investigational Site Oakland California
United States Pfizer Investigational Site Olympia Washington
United States Pfizer Investigational Site Oregon Wisconsin
United States Pfizer Investigational Site Orlando Florida
United States Pfizer Investigational Site Pawtucket Rhode Island
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Renton Washington
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Santa Ana California
United States Pfizer Investigational Site Scarborough Maine
United States Pfizer Investigational Site Troy Michigan
United States Pfizer Investigational Site Waconia Minnesota
United States Pfizer Investigational Site Walnut Creek California
United States Pfizer Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects with 5% weight loss 1 year No
Primary Change in body weight 1 year No
Secondary Blood pressure, blood lipids and glucose, waist circumference, quality of life 2 years No
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