Study:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR
Rationale:
n/a
Purpose:
The purpose of this study is to determine the effects of NB relative to placebo on major
adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial
infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk
of having these events because they have diabetes and/or other cardiovascular risk factors.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Obesity
Overweight |
Drug: NB32
Drug: PBO
Behavioral: Weight Management Program |
Phase 3 |
Verified by
Orexigen Therapeutics, Inc
May, 2013
Sponsored by: Orexigen Therapeutics, Inc
Information provided by: Orexigen Therapeutics, Inc
ClinicalTrials.gov identifier: NCT01601704
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Beachwood FHC
Beachwood, Ohio 44122
United States
The Cleveland Clinic
Cleveland, Ohio 44195
United States
Cleveland Clinic Willoughby Hills FHC
Willoughby Hills, Ohio 44094
United States
Senior Vice President, Head of Global Development., Study Director