Trials / Completed
CompletedNCT05215418
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
A Multicenter, Randomized, Double-Blind Study to Compare the Effects of VI-0521,Phentermine, and Placebo on Ambulatory Blood Pressure in Overweight or Obese Subjects
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 565 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VI-0521 | Phentermine/Topiramate Top Dose 15 mg/92 mg capsule |
| DRUG | Phentermine | Phentermine 30 mg capsule |
| DRUG | Placebo | Inactive oral capsule |
Timeline
- Start date
- 2022-01-25
- Primary completion
- 2023-04-11
- Completion
- 2023-04-17
- First posted
- 2022-01-31
- Last updated
- 2024-07-17
- Results posted
- 2024-06-18
Locations
28 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05215418. Inclusion in this directory is not an endorsement.