CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 565 enrolled
Drug / intervention
VI-0521 +2 moredrug
Likely dose
VI-0521 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05215418
NCT05215418Phase 4Completed
CompareCT.gov

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

VIVUS LLC·interventional·Posted Jan 31, 2022·Updated Jul 17, 2024

In Brief

A Phase 4 clinical trial evaluating VI-0521, Phentermine, and 1 other intervention for Blood Pressure. Completed, enrolled 565 participants across 28 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Pressure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedJan 31, 2022
Enrollment StartJan 25, 2022
Primary CompletionApr 11, 2023
Study CompletionApr 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.4 years ago

Interventions

VI-0521drug

Phentermine/Topiramate Top Dose 15 mg/92 mg capsule

Phenterminedrug

Phentermine 30 mg capsule

Placebodrug

Inactive oral capsule