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NCT00456521 · ClinicalTrials.gov registry record · Phase 3
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
A Phase 3 study, sponsored by Orexigen Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
NCT00456521 is a Phase 3 study that has completed, run by Orexigen Therapeutics. The registered enrollment target is 793 participants.
The verdict
NCT00456521, a Phase 3 study, has completed, sponsored by Orexigen Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Interventions
- DRUG Placebo
- DRUG Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
- BEHAVIORAL Intensive group lifestyle modification counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00456521
The ClinicalTrials.gov registry entry for NCT00456521 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 793 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orexigen Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00456521 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00456521 about?
NCT00456521 is a clinical study titled "A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program". The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
What is the current status of trial NCT00456521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2007-03. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00456521?
The interventions under investigation include: Placebo (DRUG), Naltrexone SR 32 mg/ bupropion SR 360 mg/ day (DRUG), Intensive group lifestyle modification counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT00456521?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
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