The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906.
This study consists of two parts, Part A and Part B. Part A is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection in patients with essential hypertension. Part B is a multicenter, open-label, long-term study designed to evaluate the long-term safety and efficacy of GW906 Injection in patients with essential hypertension. In Part A, participants are randomized to receive either GW906 Injection or placebo for 6 months. Participants who complete Part A are eligible to enter Part B and will receive GW906 Injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
319
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China
Shanghai, Shanghai Municipality, China
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg
Time frame: Baseline and Month 3
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg
Time frame: Baseline, Weeks 4, 8, and 24
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