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Trial record 1 of 1 for:    NCT00483171
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A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

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: NCT00483171
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 6, 2007
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 4, 2007
First Posted Date  ICMJE June 6, 2007
Last Update Posted Date November 7, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). [ Time Frame: 14 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • To explore the effect of CP 954, 598 on: Waist circumference [ Time Frame: 14 months ]
  • To evaluate the safety and tolerability of CP 945,598 urine and blood tests [ Time Frame: 14 months ]
  • To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [ Time Frame: 14 months ]
  • To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale [ Time Frame: 14 months ]
  • To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview [ Time Frame: 14 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2007)
  • To evaluate the safety and tolerability of CP 945,598
  • To explore the effect of CP 945,598 on:
  • Waist circumference
  • Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, total cholesterol, LDL C, HDL C, triglycerides, adiponectin
  • Patient reported outcomes
  • GAD 7 and PHQ 9 self report questionnairesnth 6 and Month 12
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
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
    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
Study Arms  ICMJE
  • 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
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 30, 2009)
699
Original Enrollment  ICMJE
 (submitted: June 4, 2007)
750
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:

  • 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
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 Australia,   Denmark,   Netherlands,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483171
Other Study ID Numbers  ICMJE A5351028
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