CLINICAL TRIALS PROFILE FOR PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
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All Clinical Trials for phentermine hydrochloride; topiramate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00518466 ↗ | Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults | Completed | VIVUS, Inc. | Phase 1 | 2007-07-01 | 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. |
| NCT00563368 ↗ | A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults | Completed | Medpace, Inc. | Phase 3 | 2007-12-01 | The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose. |
| NCT00563368 ↗ | A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults | Completed | VIVUS, Inc. | Phase 3 | 2007-12-01 | The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose. |
| NCT00600067 ↗ | A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults | Completed | Sentrx | Phase 2 | 2008-01-01 | The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial. |
| NCT00600067 ↗ | A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults | Completed | Synteract, Inc. | Phase 2 | 2008-01-01 | The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial. |
| NCT00600067 ↗ | A VI-0521 Study to Evaluate the Long-term Safety and Efficacy in Type 2 Diabetic Adults | Completed | VIVUS, Inc. | Phase 2 | 2008-01-01 | The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial. |
| NCT00737633 ↗ | Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults | Terminated | Sentrx | Phase 2 | 2008-08-01 | This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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