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Anti-obesity agent

VI-0521 for High Blood Pressure

Clinical Site, Knoxville, TN
VI-0521 +2 morePhase 4Waitlist AvailableResearch Sponsored by VIVUS LLC

Study Summary

This trial is testing whether Qsymia can help lower blood pressure, compared to a placebo and another drug called phentermine.

Eligible Conditions
  • High Blood Pressure

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Week 8 in mean systolic blood pressure as measured by 24-hr ABPM
Secondary outcome measures
Change from baseline to Week 8 in mean diastolic blood pressure as measured by 24-hr ABPM
Mean change in systolic and diastolic blood pressure from baseline to Week 8 as measured in clinic

Side effects data

From 2009 Phase 3 trial • 2487 Patients • NCT00553787
15%
constipation
14%
paresthesia
13%
dry mouth
12%
Upper Respiratory Tract Infection
11%
Nasopharyngitis
7%
sinusitis
7%
headache
7%
dizziness
7%
dysgeusia
6%
diarrhea
6%
back pain
6%
insomnia
5%
arthralgia
5%
urinary tract infection
4%
fatigue
4%
nausea
4%
bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
VI-0521 Mid
VI-0521 Top

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)Experimental Treatment1 Intervention
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
Group II: Phentermine 30mgActive Control1 Intervention
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Group III: PlaceboPlacebo Group1 Intervention
Weeks 1-8: Placebo oral capsule, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VI-0521
2008
Completed Phase 4
~6200

Find a Location

Who is running the clinical trial?

VIVUS LLCLead Sponsor
43 Previous Clinical Trials
10,049 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who qualifies as a participant in this medical trial?

"The criteria for enrollment in this trial necessitates that potential members have relatively normal blood pressure readings and are between 18-75 years old. A total of 555 participants will be recruited."

Answered by AI

Are participants currently being recruited for this investigation?

"Affirmative. Clinicaltrials.gov records show that this medical research has been actively recruiting subjects since its inception on January 25th 2022 and the most recent update was published on November 9th, 2022. This trial requires 555 patients to be recruited across a network of 25 different sites."

Answered by AI

Does the age criterion for this experiment include individuals below 25 years old?

"Participants must be of legal age (18 and above) yet under the age of 75 to join this clinical trial."

Answered by AI

Are there any medical facilities in North America currently executing this clinical trial?

"Presently, 25 clinical trial sites are running this experiment. These medical centres can be found in Salt Lake City, Evanston and Baton Rouge among others. It's beneficial to select the closest location to you if participating as it helps reduce travel needs."

Answered by AI

What health concerns arise from the ingestion of VI-0521?

"There is ample evidence suggesting VI-0521's safety, thus it received a rating of 3. This treatment has already been officially approved by regulatory bodies at the Phase 4 level."

Answered by AI

What is the upper bound of participants in this medical experiment?

"Indeed, according to clinicaltrials.gov the study is still open for recruitment, having been initially posted on January 25th 2022 and last updated on November 9th 2022. 555 individuals are needed from a total of 25 different locations."

Answered by AI

Who else is applying?

What state do they live in?
California
Alabama
Florida
How old are they?
65+
What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m always wanting to improve my health & well-being.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of VI-0521 on Ambulatory Blood Pressure in Overweight or Obese Subjects
2022. "A Study of VI-0521 on Ambulatory Blood Pressure in Overweight or Obese Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05215418.
~200 spots leftby Nov 2024
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