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Clinical trial

Naltrexone/Bupropion Cardiovascular Outcomes Study

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Last updated:1st Jan 2016

The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse cardiovascular events (MACE) when given in combination with standard of care in overweight and obese participants with documented history of CV disease.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 4 Study to Assess the Effect of Naltrexone Hydrochloride and Bupropion Hydrochloride Extended Release Combination on the Occurrence of Major Adverse Cardiovascular Events in Overweight and Obese Subjects With Cardiovascular Disease
Estimated Enrollment: 8800
Study Start Date: January 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Arms:
- Lead-In:
Naltrexone/Bupropion + Placebo
- Lead-In: Placebo + Naltrexone/Bupropion
- Active Comparator: Naltrexone/Bupropion
- Placebo Comparator: Placebo

Category Value
Study start date 2016-01-01

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