Full Text View
Tabular View
No Study Results Posted
Related Studies
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
This study has been terminated.
( See termination reason in detailed description. )
First Received: September 11, 2006   Last Updated: October 30, 2009   History of Changes
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

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Fairhope, Alabama, United States, 36532
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, California
Pfizer Investigational Site
Santa Ana, California, United States, 92705
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
Pfizer Investigational Site
Oakland, California, United States, 94609-3223
Pfizer Investigational Site
San Diego, California, United States, 92128
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
San Diego, California, United States, 92130
United States, Colorado
Pfizer Investigational Site
Longmont, Colorado, United States, 80501
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32809
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
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
Lexington, Kentucky, United States, 40509
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70809
United States, Maine
Pfizer Investigational Site
Scarborough, Maine, United States, 04074
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21204
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Pfizer Investigational Site
Troy, Michigan, United States, 48098
United States, Minnesota
Pfizer Investigational Site
Chaska, Minnesota, United States, 55318
Pfizer Investigational Site
Waconia, Minnesota, United States, 55387
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55415
Pfizer Investigational Site
Edina, Minnesota, United States, 55435
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64114
United States, New Jersey
Pfizer Investigational Site
Hamilton, New Jersey, United States, 08690
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Pfizer Investigational Site
Endwell, New York, United States, 13760
Pfizer Investigational Site
New York, New York, United States, 10021-7903
Pfizer Investigational Site
Rochester, New York, United States, 14609
Pfizer Investigational Site
Kingston, New York, United States, 12401
Pfizer Investigational Site
Manlius, New York, United States, 13104
United States, North Carolina
Pfizer Investigational Site
Burlington, North Carolina, United States, 27215
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28211
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28277
United States, North Dakota
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44311
United States, Oregon
Pfizer Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Pfizer Investigational Site
Beaver, Pennsylvania, United States, 15009
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
Pfizer Investigational Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Bristol, Tennessee, United States, 37620
Pfizer Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
Pfizer Investigational Site
Fort Worth, Texas, United States, 76135
Pfizer Investigational Site
Fort Worth, Texas, United States, 76137
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Beaumont, Texas, United States, 77701
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75390-8858
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
Pfizer Investigational Site
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Olympia, Washington, United States, 98502
Pfizer Investigational Site
Renton, Washington, United States, 98057
United States, West Virginia
Pfizer Investigational Site
Morgantown, West Virginia, United States, 26506-9136
United States, Wisconsin
Pfizer Investigational Site
Oregon, Wisconsin, United States, 53575
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2E 7C5
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8L 2X2
Pfizer Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Canada, Prince Edward Island
Pfizer Investigational Site
Charlottetown, Prince Edward Island, Canada, C1E 1J7
Canada, Quebec
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
Pfizer Investigational Site
Montreal, Quebec, Canada, H2W 1R7
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 25, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services