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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00375401 |
Purpose
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: CP-945,598 Treatment A Drug: CP-945,598 Treatment B Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 2536 |
| Study Start Date: | October 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| CP-945,598 Treatment A: Experimental |
Drug: CP-945,598 Treatment A
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
|
| CP-945,598 Treatment B: Experimental |
Drug: CP-945,598 Treatment B
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
|
| Placebo: Placebo Comparator |
Drug: Placebo
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 82 Study Locations| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A5351025 |
| Study First Received: | September 11, 2006 |
| Last Updated: | October 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00375401 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |