Phase 4Terminated
Naltrexone/Bupropion Cardiovascular Outcomes Study
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
- Sponsor
- Orexigen Therapeutics, Inc (Industry)
- Enrolment
- 67 enrolled
- Conditions
- Obesity; Cardiovascular Diseases
- Interventions
- Naltrexone HCl/Bupropion HCl ER; Placebo
- Ages
- adults, older adults
- Registry
- NCT02638129
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Time From Treatment Period Randomization to the First Confirmed Occurrence of Major Adverse Cardiovascular Events (MACE)
History
Results first posted
Last registry update
Primary completion
Started
Registered