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NCT05215418 · ClinicalTrials.gov registry record · Phase 4
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
A Phase 4 study, sponsored by VIVUS.
- Completed
- Registry status
- Phase 4
- Development phase
- 565
- Enrollment target
NCT05215418: Completed Phase 4 study, sponsored by VIVUS.
NCT05215418 is a Phase 4 study that has completed, run by VIVUS. The registered enrollment target is 565 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05215418, a Phase 4 study, has completed, sponsored by VIVUS.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 565 participants
- Enrollment target
Study Summary
The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).
Primary Outcome
The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.
Interventions
- DRUG Placebo
- DRUG Phentermine
- DRUG VI-0521
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 565 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2023-04-17 |
| Phase | Phase 4 |
What the finished NCT05215418 record still lists
NCT05215418 is an interventional study that assigns participants to a tested intervention. The registered 565 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05215418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05215418 about?
NCT05215418 is a clinical study titled "A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects". The study is being conducted to evaluate the effect of VI-0521 (Qsymia®) on blood pressure as measured by 24-hour ambulatory blood pressure monitoring, compared to both placebo and an active control (phentermine 30 mg).
What is the current status of trial NCT05215418?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 565 participants. The study started on 2022-01-25. Estimated completion is 2023-04-17.
What interventions are being tested in trial NCT05215418?
The interventions under investigation include: Placebo (DRUG), Phentermine (DRUG), VI-0521 (DRUG).
Who is sponsoring clinical trial NCT05215418?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05215418's enrollment target sits among peer trials
565 150th of 2000 higher than 1,851 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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