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| Sponsor: | VIVUS, Inc. |
|---|---|
| Information provided by: | VIVUS, Inc. |
| ClinicalTrials.gov Identifier: | NCT00518466 |
Purpose
The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: topiramate Drug: phentermine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults |
| Enrollment: | 64 |
| Study Start Date: | July 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Vivus, Inc. ( Wesley Day, VP Clinical ) |
| Study ID Numbers: | OB-102 / AA42851 |
| Study First Received: | August 16, 2007 |
| Last Updated: | November 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00518466 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity |
|
Obesity Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Overweight Central Nervous System Stimulants Protective Agents Neuroprotective Agents Phentermine Pharmacologic Actions |
Body Weight Anti-Obesity Agents Signs and Symptoms Autonomic Agents Therapeutic Uses Appetite Depressants Nutrition Disorders Topiramate Overnutrition Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |