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A multicenter, randomized, double blind, placebo controlled study comparing the safety and efficacy of naltrexone sustained release (SR)/bupropion sustained release (SR) and placebo in obese subjects

Trial Profile

A multicenter, randomized, double blind, placebo controlled study comparing the safety and efficacy of naltrexone sustained release (SR)/bupropion sustained release (SR) and placebo in obese subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2018

At a glance

  • Drugs Naltrexone/bupropion (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms COR-II
  • Sponsors Orexigen Therapeutics
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 26 Mar 2018 Based on the data from COR-I, COR-II, COR-BMOD, and COR-Diabetes trials, the Health Canada has approved CONTRAVE extended-release tablets for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults, as reported in a Valeant Canada media release.
    • 25 Apr 2017 According to an Orexigen Therapeutics media release, Health Canada has completed its screening phase and accepted for review a New Drug Submission for marketing approval of Contrave (naltrexone HCl and bupropion HCl). The regulatory submission was filed by Valeant Canada, an affiliate of Valeant Pharmaceuticals International, Inc.
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