The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension.
This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle application on BP and inflammatory biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Central Research Associates
Birmingham, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Orange County Research Center
Tustin, California, United States
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Time frame: Baseline-6 weeks
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Time frame: Baseline-Week 4
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Time frame: Baseline-Week 4
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.
Time frame: Baseline-Week 4
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