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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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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

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: CP-945,598 Behavioral: Non-pharmacological weight loss program (NPP) Behavioral: Low Calorie Diet Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 699 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: CP-945,598
CP-945,598
Non-pharmacological weight loss program (NPP) Behavioral: Non-pharmacological weight loss program (NPP)
Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP.
Low Calorie Diet Behavioral: Low Calorie Diet
Low calorie diet



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To explore the effect of CP 954, 598 on: Waist circumference [ Time Frame: 14 months ]
  2. To evaluate the safety and tolerability of CP 945,598 urine and blood tests [ Time Frame: 14 months ]
  3. To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [ Time Frame: 14 months ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483171


  Show 26 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483171     History of Changes
Other Study ID Numbers: A5351028
First Posted: June 6, 2007    Key Record Dates
Last Update Posted: November 7, 2012
Last Verified: November 2012