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A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

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Trial Profile

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Naltrexone/bupropion (Primary)
  • Indications Obesity
  • Focus Registrational; Therapeutic Use
  • Acronyms COR-I
  • Sponsors Orexigen Therapeutics [CEASED]

    • Most Recent Events

    • 06 Nov 2020 Results of post hoc analysis assessingwhether Naltrexone/Bupropion could improve renal function in adults with overweight or obesity from COR I and II, COR-BMOD studies, presented at The Obesity Society Annual Meeting Scientific Sessions 2020
    • 04 Sep 2020 Results of post hoc analysis of data from the 6 naltrexone ER/bupropion ER trials assessing the percent of subjects achieving a weight loss of 5% to 10%, 10% to 15%, and more than 15% at weeks 16, 52, 104, and 208 presented at the 2020 European and International Congress on Obesity
    • 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.
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