Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy 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)

1253

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

  • Argentina
      • Buenos Aires, Argentina, C1437JCP
        • Pfizer Investigational Site
      • Capital Federal, Argentina, C1181ACH
        • Pfizer Investigational Site
      • Cordoba, Argentina, X5000IUG
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1428
        • Pfizer Investigational Site
      • Ramos Mejia, Buenos Aires, Argentina, 1704
        • Pfizer Investigational Site
    • Cordoba
      • Villa Carlos Paz, Cordoba, Argentina, X5152HQC
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Caringbah, New South Wales, Australia, 2229
        • Pfizer Investigational Site
      • Miranda, New South Wales, Australia, 2228
        • Pfizer Investigational Site
      • Wollongong, New South Wales, Australia, 2500
        • Pfizer Investigational Site
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • Pfizer Investigational Site
      • Kippa Ring, Queensland, Australia, 4020
        • Pfizer Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Pfizer Investigational Site
      • Heidelberg, Victoria, Australia, 3081
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile, 7560356
        • Pfizer Investigational Site
      • Santiago, RM, Chile, 7600746
        • Pfizer Investigational Site
  • France
      • Armentieres, France, 59427
        • Pfizer Investigational Site
      • Lorient Cedex, France, 56322
        • Pfizer Investigational Site
      • Paris Cedex 18, France, 75877
        • Pfizer Investigational Site
      • Poitiers Cedex, France, 86021
        • Pfizer Investigational Site
      • Rennes Cedex 9, France, 35033
        • Pfizer Investigational Site
      • Strasbourg Cedex, France, 67098
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Frankfurt am Main, Germany, 60316
        • Pfizer Investigational Site
      • Hamburg, Germany, 20253
        • Pfizer Investigational Site
      • Leipzig, Germany, 04109
        • Pfizer Investigational Site
      • Mannheim, Germany, 68163
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 133-792
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 100-032
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-041
        • Pfizer Investigational Site
  • Mexico
    • SLP
      • San Luis Potosi, SLP, Mexico, 78200
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Pfizer Investigational Site
  • Sweden
      • Goteborg, Sweden, 413 45
        • Pfizer Investigational Site
      • Stockholm, Sweden, 141 86
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 25
        • Pfizer Investigational Site
  • United Kingdom
      • Bath, United Kingdom, BA2 4BY
        • Pfizer Investigational Site
      • Bath, United Kingdom, BA1 3NG
        • Pfizer Investigational Site
      • Luton, United Kingdom, LU4 0DZ
        • Pfizer Investigational Site
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Pfizer Investigational Site
    • Herts
      • Watford, Herts, United Kingdom, WD25 0EA
        • Pfizer Investigational Site
    • Wiltshire
      • Warminster, Wiltshire, United Kingdom, BA12 9AA
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pfizer Investigational Site
    • California
      • Newport Beach, California, United States, 92660-2452
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Illinois
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Pfizer Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • 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/m ; > or = 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
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
Experimental: CP-945,598 Treatment B
Drug: CP-945,598 Treatment B
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
Experimental: CP-945,598 Treatment A
Drug: CP-945,598 Treatment A
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK
Time Frame: 1-2 years
1-2 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

February 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 6, 2006

First Submitted That Met QC Criteria

November 6, 2006

First Posted (Estimate)

November 7, 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

  • A5351019

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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