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Sponsors and Collaborators: |
VIVUS, Inc. Medpace, Inc. |
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Information provided by: | VIVUS, Inc. |
ClinicalTrials.gov Identifier: | NCT00796367 |
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 at selected study sites. This is an extension study of protocol OB-303.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: VI-0521 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions. |
Estimated Enrollment: | 1000 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator
Placebo
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Drug: VI-0521
Subjects will continue to take the same treatment they were receiving when they completed study OB-303.
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2: Experimental
VI-0521 7.5 mg PHEN/46 mg TPM
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Drug: VI-0521
Subjects will continue to take the same treatment they were receiving when they completed study OB-303.
|
3: Experimental
VI-0521 15 mg PHEN/92 mg TPM
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Drug: VI-0521
Subjects will continue to take the same treatment they were receiving when they completed study OB-303.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for enrollment into this study, subjects must meet all of the following criteria:
Exclusion Criteria:
Subjects will not be included in the study if they meet any of the following:
Responsible Party: | Vivus, Inc. ( Gina Paderon ) |
Study ID Numbers: | OB-305 |
Study First Received: | November 20, 2008 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00796367 |
Health Authority: | United States: Food and Drug Administration |
Obesity |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |