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Trial record 1 of 1 for:    NCT00375401
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A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375401
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 13, 2006
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 11, 2006
First Posted Date  ICMJE September 13, 2006
Last Update Posted Date November 7, 2012
Study Start Date  ICMJE October 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2008)
  • Proportion of subjects with 5% weight loss [ Time Frame: 1 year ]
  • Change in body weight [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2006)
Change in body weight over 2 years
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
Blood pressure, blood lipids and glucose, waist circumference, quality of life [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2006)
Blood pressure, blood lipids and glucose, waist circumference, quality of life over 2 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
Official Title  ICMJE 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
Brief Summary The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: CP-945,598 Treatment A
    Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
  • Drug: CP-945,598 Treatment B
    Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
  • Drug: Placebo
    Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
Study Arms  ICMJE
  • Experimental: CP-945,598 Treatment A
    Intervention: Drug: CP-945,598 Treatment A
  • Experimental: CP-945,598 Treatment B
    Intervention: Drug: CP-945,598 Treatment B
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 4, 2009)
2536
Original Enrollment  ICMJE
 (submitted: September 11, 2006)
2000
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00375401
Other Study ID Numbers  ICMJE A5351025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP