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

November 5, 2012 updated by: Pfizer

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2536

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E 7C5
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4R 2G4
        • Pfizer Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1E 1J7
        • Pfizer Investigational Site
    • Quebec
      • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H2W 1R7
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Fairhope, Alabama, United States, 36532
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Oakland, California, United States, 94609-3223
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
      • San Diego, California, United States, 92130
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92705
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
    • Colorado
      • Longmont, Colorado, United States, 80501
        • Pfizer Investigational Site
    • Florida
      • Orlando, Florida, United States, 32809
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40223
        • Pfizer Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pfizer Investigational Site
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
    • Maine
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pfizer Investigational Site
      • Baltimore, Maryland, United States, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Milford, Massachusetts, United States, 01757
        • Pfizer Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Michigan
      • Troy, Michigan, United States, 48098
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
      • Minneapolis, Minnesota, United States, 55415
        • Pfizer Investigational Site
      • Waconia, Minnesota, United States, 55387
        • Pfizer Investigational Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Pfizer Investigational Site
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Pfizer Investigational Site
    • New York
      • Endwell, New York, United States, 13760
        • Pfizer Investigational Site
      • Kingston, New York, United States, 12401
        • Pfizer Investigational Site
      • Manlius, New York, United States, 13104
        • Pfizer Investigational Site
      • New York, New York, United States, 10021-7903
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14609
        • Pfizer Investigational Site
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28277
        • Pfizer Investigational Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Pfizer Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8858
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76137
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76135
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Olympia, Washington, United States, 98502
        • Pfizer Investigational Site
      • Renton, Washington, United States, 98057
        • Pfizer Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506-9136
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site
      • Oregon, Wisconsin, United States, 53575
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
Experimental: CP-945,598 Treatment B
Drug: CP-945,598 Treatment B
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
Experimental: CP-945,598 Treatment A
Drug: CP-945,598 Treatment A
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with 5% weight loss
Time Frame: 1 year
1 year
Change in body weight
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure, blood lipids and glucose, waist circumference, quality of life
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 11, 2006

First Submitted That Met QC Criteria

September 11, 2006

First Posted (Estimate)

September 13, 2006

Study Record Updates

Last Update Posted (Estimate)

November 7, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • A5351025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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