VI-0521 for High Blood Pressure

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
High Blood PressureVI-0521 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline to Week 8

Baseline to Week 8
Change from baseline to Week 8 in mean diastolic blood pressure as measured by 24-hr ABPM
Change from baseline to Week 8 in mean systolic 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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

VI-0521 Mid
15%constipation
14%paresthesia
13%dry mouth
12%Upper Respiratory Tract Infection
11%Nasopharyngitis
7%dysgeusia
7%dizziness
7%headache
7%sinusitis
6%insomnia
6%back pain
6%diarrhea
5%arthralgia
5%urinary tract infection
4%bronchitis
4%nausea
4%fatigue
This histogram enumerates side effects from a completed 2009 Phase 3 trial (NCT00553787) in the VI-0521 Mid ARM group. Side effects include: constipation with 15%, paresthesia with 14%, dry mouth with 13%, Upper Respiratory Tract Infection with 12%, Nasopharyngitis with 11%.

Trial Design

3 Treatment Groups

Phentermine 30mg
1 of 3
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

555 Total Participants · 3 Treatment Groups

Primary Treatment: VI-0521 · Has Placebo Group · Phase 4

VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Drug
Experimental Group · 1 Intervention: VI-0521 · Intervention Types: Drug
Phentermine 30mg
Drug
ActiveComparator Group · 1 Intervention: Phentermine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VI-0521
2008
Completed Phase 3
~5640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 8

Who is running the clinical trial?

VIVUS LLCLead Sponsor
43 Previous Clinical Trials
10,039 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.

Who else is applying?

What state do they live in?
California50.0%
Florida50.0%
How old are they?
65+100.0%
What site did they apply to?
Clinical Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%