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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00391196 |
The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 Obesity |
Drug: Placebo Drug: CP-945,598 Drug: CP-945,598 Treatment B |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 1-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Efficacy And Safety Of CP-945,598 In The Treatment Of Overweight, Oral Agent-Treated Subjects With Type 2 Diabetes Mellitus |
Enrollment: | 974 |
Study Start Date: | November 2006 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator |
Drug: Placebo
Subjects receive placebo plus non-pharmacological weight loss program.
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CP-945,598: Experimental |
Drug: CP-945,598
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
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CP-945,598 Treatment B: Experimental
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
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Drug: CP-945,598 Treatment B
Subjects receive CP-945,598 plus non-pharmacological weight loss program.
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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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A5351022 |
Study First Received: | October 19, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00391196 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Nutrition Disorders Endocrine System Diseases Overweight Overnutrition Glucose Metabolism Disorders |