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 as add-on therapy.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy, safety, and pharmacokinetics of GW906 Injection used as add-on therapy in patients with hypertension not adequately controlled by one or two antihypertensive medications. Participants are randomized to receive either GW906 Injection or placebo for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
560
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 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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