A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 [phentermine/topiramate] to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults.

Trial Profile

A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 [phentermine/topiramate] to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2013

At a glance

  • Drugs Phentermine/topiramate (Primary) ; Phentermine; Topiramate
  • Indications Obesity; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms EQUATE
  • Sponsors VIVUS
  • Most Recent Events

    • 17 Oct 2013 Primary endpoint 'Greater-than-5%-reduction-of-bodyweight' has been met.
    • 05 Oct 2012 Results reporting cardiovascular outcomes presented at the 48th Annual Meeting of the European Association for the Study of Diabetes.
    • 06 May 2010 The New Drug Application has been accepted by the FDA, with an action date of 28 October 2010.
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