drugset / Trial / NCT02638129

Naltrexone/Bupropion Cardiovascular Outcomes Study

NCT02638129

Phase 4 Terminated 67 enrolled Orexigen Therapeutics, Inc
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2016-01
Primary completion
2016-06
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 90 mg
Subject Naltrexone Small molecule 8 mg