The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
Phase 2b, multicenter, randomized, double-blind, placebo-controlled, 12 months treatment study to assess the efficacy, safety, and pharmacodynamics of QCZ484 with mild to moderate hypertension (HTN). Multiple doses of QCZ484 will be tested against placebo, administered as subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
396
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 3 in mean 24hr systolic blood pressure (SBP) by ambulatory blood pressure measurement (ABPM)
Time frame: Baseline, Month 3
Change in Mean 24hr SBP by ABPM
Change from baseline at Month 6 in mean 24hr SBP by ABPM
Time frame: Baseline, Month 6
Change in SBP by OBPM
Change from baseline at Month 3 and 6 in SBP by office blood pressure measurement (OBPM)
Time frame: Baseline, Month 3 and 6
Participants achieving SBP<130 mmHg or SBP reduced by ≥10 mmHg by ABPM
Proportion of responders defined as participants achieving SBP\<130 mmHg or SBP reduced by ≥10 mmHg from baseline, at Month 3 and 6 by ABPM
Time frame: Baseline, Month 3 and 6
Change in DBP by ABPM and OBPM
Change from baseline at Month 3 and 6 on diastolic blood pressure (DBP) by ABPM and OBPM
Time frame: Baseline, Month 3 and 6
Number of participants with AEs
Number of participants with AEs by treatment group, including changes in vital signs and laboratory results qualifying and reported as AEs.
Time frame: Up to Month 18
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