Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

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NCT00396448

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Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnancy


- Diabetes


- Adults with serious or unstable current or past medical conditions

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Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy 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 B
    Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
  • Drug: CP-945,598 Treatment A
    Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
  • Drug: Placebo
    Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
Study Arms  ICMJE
  • Experimental: CP-945,598 Treatment B
    Intervention: Drug: CP-945,598 Treatment B
  • Experimental: CP-945,598 Treatment A
    Intervention: Drug: CP-945,598 Treatment A
  • 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: October 28, 2009)		1253
Original Enrollment  ICMJE
 (submitted: November 6, 2006)		1500
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Argentina,   Australia,   Chile,   France,   Germany,   Korea, Republic of,   Mexico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00396448
Other Study ID Numbers  ICMJE A5351019
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 CenterPfizer
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