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A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions

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Trial Profile

A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2021

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At a glance

  • Drugs Phentermine/topiramate (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms SEQUEL
  • Sponsors VIVUS

    • Most Recent Events

    • 07 Oct 2019 According to an VIVUS media release, under the decentralized MAA procedure, the regulatory authorities in each of the Concerned Member States may simultaneously provide Marketing Authorization for use of a product within those specific countries. The company anticipates the completion of the MAA assessment and, if approved, Marketing Authorizations to begin in the second half of 2020.
    • 07 Oct 2019 According to an VIVUS media release, the European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have accepted the Marketing Authorization Application (MAA) for Qsymia(phentermine and topiramate extended-release) on a decentralized basis, with Sweden acting as the lead Concerned Member State,for purposes of assessing the MAA.
    • 02 May 2017 New trial record
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