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

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: Placebo Drug: CP-945,598 Treatment B	Phase III

MedlinePlus related topics:

Obesity Weight Control

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Estimated Enrollment:	2500
Study Start Date:	October 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

Eligibility

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:

Contacts and Locations

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

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351025
First Received:	September 11, 2006
Last Updated:	August 3, 2008
ClinicalTrials.gov Identifier:	NCT00375401
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Weight Loss

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on September 05, 2008

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