The purpose of this study is to evaluate the efficacy, safety and tolerability of IBI3016 or placebo, given subcutaneously, every 3 or 6 months, at different dose levels in patients with mild to moderate hypertension
Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and pharmacodynamics of IBI3016 in patients with mild to moderate hypertension. Multiple doses of IBI3016 will be tested against placebo, administered as subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
352
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Change in SBP by OBPM
Change from baseline at Month 3 in systolic blood pressure (SBP) by office blood pressure measurement (OBPM)
Time frame: From baseline through month 3
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 3 in mean 24hr SBP by ambulatory blood pressure measurement (ABPM)
Time frame: From baseline through month 3
Change in SBP and DBP by OBPM
Change from baseline through month 6 in SBP and diastolic blood pressure (DBP) by OBPM
Time frame: From baseline through month 6
Change in Mean 24hr, mean daytime, mean nighttime SBP and DBP by ABPM
From baseline through month 6
Time frame: Change from baseline through month 6 in Mean 24hr, mean daytime, mean nighttime SBP and DBP by OBPM
Percentage Change in AGT by blood test
Percentage Change from baseline through month 24 in Angiotensinogen (AGT) by blood test
Time frame: From baseline through month 24
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