Trial Profile
A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release (SR)/Bupropion 360 mg Sustained Release (SR) and Placebo in Obese Subjects With Type 2 Diabetes Mellitus
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 17 Sep 2021
Price :
$35 *
At a glance
- Drugs Naltrexone/bupropion (Primary)
- Indications Obesity
- Focus Registrational; Therapeutic Use
- Acronyms COR-Diabetes
- Sponsors Orexigen Therapeutics [CEASED]
- 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.
- 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.