A Multicenter, Randomized, Double-blind, and Active-controlled Parallel Study to Evaluate the Efficacy and Safety of QR12000 Compound Tablets and Sacubitril/valsartan Tablets in Patients with Moderate to Severe Essential Hypertension
Overview
- Phase
- Phase 3
- Intervention
- QR12000 75mg
- Conditions
- Essential Hypertension
- Sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Enrollment
- 810
- Primary Endpoint
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who can understand and are willing to complying with protocol requirement and sign the informed consent form.
- •Man or woman aged 18 years to 75 years (inclusive), with BMI≤30 kg/m
- •Patients with moderate to severe hypertension. Untreated patients must have an msSBP ≥ 160 mmHg and \< 190 mmHg at the screening and randomization visit; Treated patients must have an msSBP≥150 mmHg and \<180 mmHg or msSBP≥140 mmHg and \<170 mmHg at the screening visit based on numbers of antihypertensive and msSBP≥160 mmHg \<190 mmHg at the randomization visit; Patients must have an absolute difference of ≤20 mmHg in msSBP between randomization visit and the immediately preceding visit.
- •Subjects who agree to use adequate contraception from 2 weeks prior to screening to 1 month after last dose.
Exclusion Criteria
- •History or evidence of a secondary form of hypertension.
- •History of peripheral arterial occlusive disease and Raynaud's syndrome.
- •History of hyperthyroidism.
- •History of hypotension.
- •History of angioedema, drug-related or otherwise.
- •Suffered by severe cerebrovascular disease within 1 year prior to screening.
- •Suffered by severe heart disease within 1 year prior to screening
- •History of severe or malignant retinopathy.
- •History of aortic aneurysm or dissection, cardiac surgery, or percutaneous coronary intervention within 1 year prior to screening.
- •History of malignant tumor within 5 years prior to screening.
Arms & Interventions
QR12000 75mg
Participants will be treated with one tablet of QR12000 75mg, one tablet of QR12000 150mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 75mg
QR12000 75mg
Participants will be treated with one tablet of QR12000 75mg, one tablet of QR12000 150mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 150mg placebo
QR12000 75mg
Participants will be treated with one tablet of QR12000 75mg, one tablet of QR12000 150mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: Sacubitril/valsartan 200mg placebo
QR12000 150mg
Participants will be treated with one tablet of QR12000 150mg, one tablet of QR12000 75mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 75mg placebo
QR12000 150mg
Participants will be treated with one tablet of QR12000 150mg, one tablet of QR12000 75mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 150mg
QR12000 150mg
Participants will be treated with one tablet of QR12000 150mg, one tablet of QR12000 75mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: Sacubitril/valsartan 200mg placebo
Sacubitril/valsartan 200 mg
Participants will be treated with one tablet of Sacubitril/valsartan 200 mg, one tablet of QR12000 75mg placebo and one tablet of QR12000 150mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 75mg placebo
Sacubitril/valsartan 200 mg
Participants will be treated with one tablet of Sacubitril/valsartan 200 mg, one tablet of QR12000 75mg placebo and one tablet of QR12000 150mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: QR12000 150mg placebo
Sacubitril/valsartan 200 mg
Participants will be treated with one tablet of Sacubitril/valsartan 200 mg, one tablet of QR12000 75mg placebo and one tablet of QR12000 150mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Intervention: Sacubitril/valsartan 200mg
Outcomes
Primary Outcomes
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time Frame: Baseline and week 8
The change in msSBP measured at Week 8 relative to baseline.
Secondary Outcomes
- Change From Baseline in Mean Sitting Diastolic BP (msDBP)(Baseline and week 8)
- Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)(Baseline and week 8)
- Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP(Baseline and week 8)
- Percentage of Participants Achieving BP Control(Baseline and week 8)
- Percentage of Participants Achieving BP Response(Baseline and week 8)
- Change From Baseline in msSBP/msDBP(Baseline, week 28 and week 52)