A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase II trial of VB19055 for 12 weeks in 240 adults with uncontrolled hypertension (including resistant hypertension).
This study is a multicenter, randomized, double-blind, placebo parallel-controlled, dose-ranging Phase II clinical trial designed to evaluate the efficacy and safety of 12-week treatment with VB19055 in trial participants with hypertension (including resistant hypertension) whose blood pressure remains uncontrolled despite treatment with two or more antihypertensive medications, and to explore the dosing regimen for confirmatory studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
VB19055 Dose A orally once daily (QD) for 12 weeks
VB19055 DoseB orally once daily (QD) for 12 weeks
VB19055 Dose C orally once daily (QD) for 12 weeks
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, China
Change from baseline in seated clinic systolic blood pressure at Week 12.
Time frame: at the end of the 12-week treatment period
Change from baseline in seated clinic diastolic blood pressure at Week 12
Time frame: at the end of the 12-week treatment period
Percentage of participants with a seated blood pressure of less than 140/90 mmHg at the end of the 12-week treatment period
Time frame: at the end of the 12-week treatment period
Percentage of participants with a seated blood pressure of less than 130/80 mmHg at the end of the 12-week treatment period
Time frame: at the end of the 12-week treatment period
Change from baseline in mean SBP and DBP, daytime SBP and DBP, nighttime SBP and DBP, and trough-to-peak ratio (T/P) of SBP and DBP by ambulatory blood pressure monitoring (ABPM) at Week 12
Time frame: at the end of the 12-week treatment period
Adverse events, including treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), TEAEs leading to permanent discontinuation, adverse events of special interest (AESI), etc.
Time frame: 12-week treatment period
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VB19055 placebo orally once daily (QD) for 12 weeks
Peking University People's Hospital
Beijing, China
The Third Hospital of Changsha
Changsha, China
The Third Xiangya Hospital of Central South University
Changsha, China
Chengdu Second People's Hospital
Chengdu, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Daqing People's Hospital
Daqing, China
The First Hospital of Hebei Medical University
Hebei, China
The First Affiliated Hospital of University of South China
Hengyang, China
Affiliated Hospital of Jining Medical University
Jining, China
...and 14 more locations