A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients

NCT00391196

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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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

- Subjects must be overweight (BMI 27- 50 kg/m2)

- Subjects must have type 2 diabetes mellitus

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


- Pregnancy


- Serious or unstable current or past medical conditions

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients
Official Title  ICMJE A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus
Brief Summary The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
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: Placebo
    Subjects receive placebo plus non-pharmacological weight loss program.
  • Drug: CP-945,598
    Subjects receive CP-945,598 plus non-pharmacological weight loss program.
  • Drug: CP-945,598 Treatment B
    Subjects receive CP-945,598 plus non-pharmacological weight loss program.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: CP-945,598
    Intervention: Drug: CP-945,598
  • Experimental: CP-945,598 Treatment B
    Subjects receive CP-945,598 plus non-pharmacological weight loss program.
    Intervention: Drug: CP-945,598 Treatment B
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 27, 2009)
975
Original Enrollment  ICMJE
 (submitted: October 19, 2006)
900
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must be overweight (BMI 27- 50 kg/m2)
  • Subjects must have type 2 diabetes mellitus

Exclusion Criteria:

  • Pregnancy
  • 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,   Brazil,   Canada,   Czech Republic,   Germany,   Mexico,   Slovakia,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00391196
Other Study ID Numbers  ICMJE A5351022
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