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A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

NCT05215418 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2024-07-17

Study results available
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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

  • Blood Pressure

Interventions

DRUG

VI-0521

Phentermine/Topiramate Top Dose 15 mg/92 mg capsule

DRUG

Phentermine

Phentermine 30 mg capsule

DRUG

Placebo

Inactive oral capsule

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-04-11
Completion
2023-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05215418 on ClinicalTrials.gov