| Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety. |
| A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects |
| The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults |
| 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. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Obesity |
- Drug: CP-945,598 Treatment B
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
- Drug: CP-945,598 Treatment A
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
- Drug: Placebo
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
|
- Experimental: CP-945,598 Treatment B
Intervention: Drug: CP-945,598 Treatment B
- Experimental: CP-945,598 Treatment A
Intervention: Drug: CP-945,598 Treatment A
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
|
| Not Provided |
| |
| Terminated |
| 1253 |
| February 2009 |
| February 2009 (Final data collection date for primary outcome measure) |
|
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
Exclusion Criteria:
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Australia, Chile, France, Germany, Korea, Republic of, Mexico, Spain, Sweden, United Kingdom, United States |
| |
| |
| NCT00396448 |
| A5351019 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| November 2012 |
