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

NCT ID: NCT00375401

Last Updated: 2012-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CP-945,598 Treatment A

Group Type EXPERIMENTAL

CP-945,598 Treatment A

Intervention Type DRUG

Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling

CP-945,598 Treatment B

Group Type EXPERIMENTAL

CP-945,598 Treatment B

Intervention Type DRUG

Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling

Interventions

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CP-945,598 Treatment A

Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling

Intervention Type DRUG

CP-945,598 Treatment B

Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling

Intervention Type DRUG

Placebo

Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fairhope, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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La Jolla, California, United States

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Oakland, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Walnut Creek, California, United States

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Longmont, Colorado, United States

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Orlando, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Scarborough, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Milford, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Troy, Michigan, United States

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Chaska, Minnesota, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Waconia, Minnesota, United States

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Kansas City, Missouri, United States

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Hamilton, New Jersey, United States

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Albuquerque, New Mexico, United States

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Endwell, New York, United States

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Kingston, New York, United States

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Manlius, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Fargo, North Dakota, United States

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Akron, Ohio, United States

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Medford, Oregon, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Cumberland, Rhode Island, United States

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Pawtucket, Rhode Island, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Olympia, Washington, United States

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Renton, Washington, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Oregon, Wisconsin, United States

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Calgary, Alberta, Canada

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Winnipeg, Manitoba, Canada

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Hamilton, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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L'Ancienne-Lorette, Quebec, Canada

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Montreal, Quebec, Canada

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Countries

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United States Canada

Related Links

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Other Identifiers

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A5351025

Identifier Type: -

Identifier Source: org_study_id