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A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

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NCT00483171

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Jolla, California, 92037 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities;
>/=27 kg/m2 for subjects with co morbidities

- Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled
visits, treatment plan, laboratory tests, and other trial procedures.

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

- Participation in a formal weight loss program or significant weight loss (fluctuation
>5% of total body weight) in the past 3 months.

- Subjects with serious medical or psychiatric conditions

NCT00483171
Pfizer
Terminated
A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

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A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
A 14-Month, Randomized, Double-Blind,Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety of CP-945,598 In Prevention Of Weight Regain In Obese Subjects
The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Obesity
  • Drug: CP-945,598
    CP-945,598
  • Behavioral: Non-pharmacological weight loss program (NPP)
    Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
  • Behavioral: Low Calorie Diet
    Low calorie diet
  • Placebo Comparator: Placebo
    Intervention: Drug: CP-945,598
  • Non-pharmacological weight loss program (NPP)
    Intervention: Behavioral: Non-pharmacological weight loss program (NPP)
  • Low Calorie Diet
    Intervention: Behavioral: Low Calorie Diet
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
699
January 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be overweight (BMI) >/=30 kg/m2, for subjects without co morbidities; >/=27 kg/m2 for subjects with co morbidities
  • Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  • Participation in a formal weight loss program or significant weight loss (fluctuation >5% of total body weight) in the past 3 months.
  • Subjects with serious medical or psychiatric conditions
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   Netherlands,   South Africa,   United States
 
 
NCT00483171
A5351028
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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