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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483171
First received: June 4, 2007
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the effect of CP 954, 598 on: Waist circumference [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of CP 945,598 urine and blood tests [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 699
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483171

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00483171     History of Changes
Other Study ID Numbers: A5351028
Study First Received: June 4, 2007
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014