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Naltrexone/Bupropion Cardiovascular Outcomes Study

NCT02638129 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-02-27

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02638129 on ClinicalTrials.gov