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NCT02638129 · ClinicalTrials.gov registry record · Phase 4
Naltrexone/Bupropion Cardiovascular Outcomes Study
A Phase 4 study, sponsored by Orexigen Therapeutics.
- Terminated
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
NCT02638129: Clinical Trial Phase 4 study, sponsored by Orexigen Therapeutics.
NCT02638129 is a Phase 4 study that was terminated before completion, run by Orexigen Therapeutics. The registered enrollment target is 67 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02638129, a Phase 4 study, was terminated before completion, sponsored by Orexigen Therapeutics.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.
Interventions
- DRUG Placebo
- DRUG Naltrexone HCl/Bupropion HCl ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2016-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
Why NCT02638129 stopped before completion
NCT02638129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02638129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02638129 about?
NCT02638129 is a clinical study titled "Naltrexone/Bupropion Cardiovascular Outcomes Study". 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 ov...
What is the current status of trial NCT02638129?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2016-01. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02638129?
The interventions under investigation include: Placebo (DRUG), Naltrexone HCl/Bupropion HCl ER (DRUG).
Who is sponsoring clinical trial NCT02638129?
This trial is sponsored by Orexigen Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02638129's enrollment target sits among peer trials
67 1083rd of 2000 higher than 918 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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