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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00483171
First received: June 4, 2007
Last updated: November 5, 2012
Last verified: November 2012
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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
Show 26 Study LocationsSponsors 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 June 18, 2013