Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.
Phase 3
Terminated
- Conditions
- Obesity
- Interventions
- Drug: CP-945,598 Treatment BDrug: CP-945,598 Treatment ADrug: Placebo
- Registration Number
- NCT00396448
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1253
Inclusion Criteria
- Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
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Exclusion Criteria
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CP-945,598 Treatment B CP-945,598 Treatment B - CP-945,598 Treatment A CP-945,598 Treatment A - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change in body weight and proportion of subjects with 5% weight loss 1 year
- Secondary Outcome Measures
Name Time Method Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK 1-2 years
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇬🇧Northwood, Middlesex, United Kingdom