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Last Updated: November 16, 2019

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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 >Phase >Start Date >Summary

Clinical Trial Conditions for Phentermine Hydrochloride; Topiramate

Condition Name

Condition Name for Phentermine Hydrochloride; Topiramate
Intervention Trials
Obesity 8
Diabetes 2
Binge Eating Disorder 2
Adolescent Obesity 1
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Condition MeSH

Condition MeSH for Phentermine Hydrochloride; Topiramate
Intervention Trials
Obesity 5
Overweight 3
Feeding and Eating Disorders 2
Obesity, Morbid 2
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Clinical Trial Locations for Phentermine Hydrochloride; Topiramate

Trials by Country

Trials by Country for Phentermine Hydrochloride; Topiramate
Location Trials
United States 25
Italy 1
Mexico 1
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Trials by US State

Trials by US State for Phentermine Hydrochloride; Topiramate
Location Trials
California 5
Texas 2
Maryland 2
Alabama 2
Ohio 2
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Clinical Trial Progress for Phentermine Hydrochloride; Topiramate

Clinical Trial Phase

Clinical Trial Phase for Phentermine Hydrochloride; Topiramate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Phentermine Hydrochloride; Topiramate
Clinical Trial Phase Trials
Completed 8
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Phentermine Hydrochloride; Topiramate

Sponsor Name

Sponsor Name for Phentermine Hydrochloride; Topiramate
Sponsor Trials
VIVUS, Inc. 7
Lindner Center of HOPE 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 2
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Sponsor Type

Sponsor Type for Phentermine Hydrochloride; Topiramate
Sponsor Trials
Other 15
Industry 14
NIH 4
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