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

Tracking Information

First Received Date ^ICMJE

September 11, 2006

Last Updated Date

October 30, 2009

Start Date ^ICMJE

October 2006

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects with 5% weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in body weight over 2 years

Change History

Complete list of historical versions of study NCT00375401 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood pressure, blood lipids and glucose, waist circumference, quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Blood pressure, blood lipids and glucose, waist circumference, quality of life over 2 years

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: CP-945,598 Treatment A
Drug: CP-945,598 Treatment B
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

2536

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00375401

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A5351025

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP