Who is sponsoring NCT01601704?

NCT01601704 is sponsored by Orexigen Therapeutics, Inc.

What condition does NCT01601704 study?

NCT01601704 studies Obesity, Overweight.

What drugs are being tested in NCT01601704?

Interventions: NB32, PBO, Weight Management Program.

What is the status of NCT01601704?

NCT01601704 is currently TERMINATED.

Last reviewed 2017-02-24 · How we verify

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

NCT01601704 Phase 3 TERMINATED Results posted

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.

Details

Lead sponsor	Orexigen Therapeutics, Inc
Phase	Phase 3
Status	TERMINATED
Enrolment	8910
Start date	2012-06
Completion	2015-08

Conditions

Obesity
Overweight

Interventions

NB32
PBO
Weight Management Program

Primary outcomes

Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) — Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.

Countries

United States