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NCT01764386 · ClinicalTrials.gov registry record · Phase 3
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
A Phase 3 study of Obesity and Overweight, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
- 15
- Study locations
NCT01764386 is a Phase 3 study of Obesity and Overweight that has completed, run by Orexigen Therapeutics. The registered enrollment target is 242 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (70% lower). The trial reports 15 study locations across 8 states.
The verdict
NCT01764386, a Phase 3 study of Obesity and Overweight, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- DRUG NB
- BEHAVIORAL CLI
Study Locations (15)
North Carolina
- PMG Research of Raleigh - Cary
- PMG Research of Winston-Salem - Hickory
- PMG Research of Raleigh - Raleigh
- PMG Research of Salisbury - Salisbury
- PMG Research of Wilmington, LLC - Wilmington
South Carolina
- Radiant Research - Anderson
- Radiant Research, Greer - Greer
- PMG Research of Charleston - Mt. Pleasant
Ohio
- Radiant Research-Akron - Akron
- Radiant Research, Inc. - Columbus
Colorado
- Radiant Research - Denver
Missouri
- Radiant Research, Inc. - St Louis
Tennessee
- PMG Research of Bristol - Bristol
Texas
- Radiant Research Dallas-North - Dallas
Utah
- Radiant Research, SLC - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01764386
The ClinicalTrials.gov registry entry for NCT01764386 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 242 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (70% lower). The listed sponsor is Orexigen Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Usual Care is the first listed.
NCT01764386 reports 15 study locations spanning 8 distinct geographic areas - top geographies include North Carolina, South Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT01764386 about?
NCT01764386 is a clinical study titled "Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects". The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular r...
What is the current status of trial NCT01764386?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2013-02. Estimated completion is 2014-09.
What conditions does trial NCT01764386 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT01764386?
The interventions under investigation include: Usual Care (BEHAVIORAL), NB (DRUG), CLI (BEHAVIORAL).
Who is sponsoring clinical trial NCT01764386?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01764386 being conducted?
This trial has 15 study locations across Colorado, Missouri, North Carolina, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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