NCT02638129

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being evaluated in this study is naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB). NB is being evaluated in this study to rule out excess cardiovascular risk. This study will evaluate the occurrence of major adverse CV events in participants who take NB compared with placebo given in combination with standard of care in overweight and obese participants with documented history of CV disease. The study will enroll approximately 8800 patients. After a 2-week lead-in period evaluating tolerance to NB (participants were randomly assigned in a 1:1 ratio to 1 week of NB \[1 tablet per day\] followed by 1 week of placebo \[1 tablet per day\] or 1 week of placebo followed by 1 week of NB), participants will be randomly assigned to one of two treatment groups in a 1:1 ratio, which will remain undisclosed to the patient, study site personnel, and investigator/study physician during the study (unless there is an urgent medical need): * Naltrexone HCl 8 mg/bupropion 90 mg extended release combination tablets * Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take tablet(s) in the AM and PM at the same time each day throughout the study. This multi-center trial will be conducted in the United States. The overall time to participate in this study is up to 6 years. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Conditions

• Obesity
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Naltrexone HCl/Bupropion HCl ER	Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
DRUG	Placebo	Naltrexone HCl/bupropion HCl placebo-matching tablets

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-12-22
• Last updated: 2017-02-27
• Results posted: 2017-02-27

Locations

139 sites across 1 country: United States