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NCT00396448 Clinical Trial

Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy 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 NCT00396448
Other study ID # A5351019
Secondary ID
Status Terminated
Phase Phase 3
First received November 6, 2006
Last updated November 5, 2012
Start date February 2007
Est. completion date February 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 1253
Est. completion date February 2009
Est. primary completion date February 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/m ; > or = 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 B
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
• CP-945,598 Treatment A
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
• Placebo
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Capital Federal
Argentina Pfizer Investigational Site Capital Federal Buenos Aires
Argentina Pfizer Investigational Site Cordoba
Argentina Pfizer Investigational Site Ramos Mejia Buenos Aires
Argentina Pfizer Investigational Site Villa Carlos Paz Cordoba
Australia Pfizer Investigational Site Caboolture Queensland
Australia Pfizer Investigational Site Caringbah New South Wales
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Heidelberg Victoria
Australia Pfizer Investigational Site Kippa Ring Queensland
Australia Pfizer Investigational Site Miranda New South Wales
Australia Pfizer Investigational Site Wollongong New South Wales
Chile Pfizer Investigational Site Santiago RM
Chile Pfizer Investigational Site Santiago RM
France Pfizer Investigational Site Armentieres
France Pfizer Investigational Site Lorient Cedex
France Pfizer Investigational Site Paris Cedex 18
France Pfizer Investigational Site Poitiers Cedex
France Pfizer Investigational Site Rennes Cedex 9
France Pfizer Investigational Site Strasbourg Cedex
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Frankfurt am Main
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Mannheim
Germany Pfizer Investigational Site Muenchen
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Korea, Republic of Pfizer Investigational Site Seoul
Mexico Pfizer Investigational Site San Luis Potosi SLP
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Santiago de Compostela La Coruña
Spain Pfizer Investigational Site Valencia
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uppsala
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Luton
United Kingdom Pfizer Investigational Site Northwood, Middlesex
United Kingdom Pfizer Investigational Site Warminster Wiltshire
United Kingdom Pfizer Investigational Site Watford Herts
United States Pfizer Investigational Site Anderson South Carolina
United States Pfizer Investigational Site Bountiful Utah
United States Pfizer Investigational Site Cary North Carolina
United States Pfizer Investigational Site Farmington Hills Michigan
United States Pfizer Investigational Site Johnson City Tennessee
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Newport Beach California
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Peoria Arizona
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Springfield Illinois
United States Pfizer Investigational Site Wilmington North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Chile,  France,  Germany,  Korea, Republic of,  Mexico,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in body weight and proportion of subjects with 5% weight loss 1 year No
Secondary Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK 1-2 years No
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