The purpose of the study is to evaluate the efficacy and safety of QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in patients with moderate to severe essential hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
810
Peking University First Hospital
Beijing, Beijing Municipality, China
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
The change in msSBP measured at Week 8 relative to baseline.
Time frame: Baseline and week 8
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
The change in msDBP measured at Week 8 relative to baseline.
Time frame: Baseline and week 8
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)
The change in maSBP/maDBP measured at Week 8 relative to baseline.
Time frame: Baseline and week 8
Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP
The change in Daytime or Nighttime maSBP/maDBP measured at Week 8 relative to baseline.
Time frame: Baseline and week 8
Percentage of Participants Achieving BP Control
BP control is defined as msSBP \<140 mm Hg and msDBP \<90 mm Hg.
Time frame: Baseline and week 8
Percentage of Participants Achieving BP Response
BP Response is defined as msSBP \<140 mm Hg and/or a reduction of ≥20 mm Hg from Baseline and msDBP \<90 mm Hg and/or a reduction of ≥10 mm Hg from Baseline.
Time frame: Baseline and week 8
Change From Baseline in msSBP/msDBP
The change in msSBP/msDBP measured at Week 28 and Week 52 relative to baseline.
Time frame: Baseline, week 28 and week 52
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Matching placebo of QR12000 150mg QD
Sacubitril/valsartan 200mg QD
Matching placebo of Sacubitril/valsartan 200mg QD