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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00375401

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: CP-945,598 Treatment A Drug: CP-945,598 Treatment B Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	2536
Study Start Date:	October 2006
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-945,598 Treatment A: Experimental	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: Experimental	Drug: CP-945,598 Treatment B Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Placebo: Placebo Comparator	Drug: Placebo Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375401

Show 82 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351025
Study First Received:	September 11, 2006
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00375401 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on November 09, 2009