Status:
COMPLETED
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Lead Sponsor:
VIVUS LLC
Conditions:
Blood Pressure
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 (...
Eligibility Criteria
Inclusion
- Overweight/obese adult males/females 18-75 years of age with a BMI ≥ 27 kg/m2;
- At least 1 weight-related comorbidity (i.e., hypertension, dyslipidemia, Type 2 diabetes mellitus \[T2DM\] or prediabetes, or obstructive sleep apnea).
- Must be ambulatory, willing, and able to wear ABPM monitor apparatus for 24 hours at beginning and end of study.
Exclusion
- Screening blood pressure of \> 140/90 mmHg;
- Type 1 diabetes; T2DM treated with SFUs, GLP-1 receptor agonists, SGLT inhibitors; or not on stable diabetic medications for at least 3 months prior to randomization;
- Clinically significant cardiac, hepatic, renal, pulmonary, or thyroid disease;
- History of bipolar disorder, psychosis, greater than one lifetime episode of major depressive disorder, or presence or history of suicidal behavior or suicidal ideation with intent to act;
- History of glaucoma;
- Night shift workers;
- Obesity of known genetic or endocrine origin; recent history of weight instability, or recent participation in a formal weight loss program within 3 months prior to screening; and
- Smoking cessation within 3 months prior to screening;
- Use of antihypertensive medications, antidiabetic medications, statins or other lipid lowering agents, or CPAP therapy that has not been stable for at least 3 months prior to randomization;
- COVID-19 vaccination or treatment for severe COVID-19 infection within a month prior to randomization.
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2023
Estimated Enrollment :
565 Patients enrolled
Trial Details
Trial ID
NCT05215418
Start Date
January 25 2022
End Date
April 17 2023
Last Update
July 17 2024
Active Locations (28)
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1
Clinical Site
Anniston, Alabama, United States, 36207
2
Clinical Site
Mobile, Alabama, United States, 36608
3
Clinical Site
Lincoln, California, United States, 95648
4
Clinical Site
Long Beach, California, United States, 90806