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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215418
• Other study ID #: OB-409
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2022
• Est. completion date: April 17, 2023

Study information

• Verified date: May 2024
• Source: VIVUS LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 565
• Est. completion date: April 17, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Blood Pressure
• Overweight

Intervention

Drug:
• VI-0521
Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
• Phentermine
Phentermine 30 mg capsule
• Placebo
Inactive oral capsule

Locations

Country	Name	City	State
United States	Clinical Site	Anniston	Alabama
United States	Clinical Site	Baton Rouge	Louisiana
United States	Clinical Site	Brownsburg	Indiana
United States	Clinical Site	Butte	Montana
United States	Clinical Site	Cary	North Carolina
United States	Clinical Site	Columbia	South Carolina
United States	Clinical Site	Coral Gables	Florida
United States	Clinical Site	Eugene	Oregon
United States	Clinical Site	Evansville	Indiana
United States	Clinical Site	Friendswood	Texas
United States	Clinical Site	Kansas City	Missouri
United States	Clinical Site	Knoxville	Tennessee
United States	Clinical Site	Lexington	Kentucky
United States	Clinical Site	Lincoln	California
United States	Clinical Site	Long Beach	California
United States	Clinical Site	Louisville	Kentucky
United States	Clinical Site	Miami	Florida
United States	Clinical Site	Mobile	Alabama
United States	Clinical Site	Norfolk	Virginia
United States	Clinical Site	North Richland Hills	Texas
United States	Clinical Site	Port Orange	Florida
United States	Clinical Site	Sacramento	California
United States	Clinical site	Salt Lake City	Utah
United States	Clinical Site	San Antonio	Texas
United States	Clinical Site	Spring Valley	California
United States	Clinical Site	Upland	California
United States	Clinical Site	Washington	District of Columbia
United States	Clinical Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM	The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.	Baseline to Week 8
Secondary	Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM	The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.	Baseline to Week 8
Secondary	Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic	The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure.	Baseline to Week 8