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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 810
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Poorly controlled diabetes prior to screening
- •History of severe autoimmune diseases.
- •History of severe mental disorder.
- •Clinically significant laboratory abnormalities.
- •History of allergy to the test drug, active control drug, or drugs similar to the test drug and positive control drug or related excipients.
- •Undergone gastrointestinal surgery that could significantly alter drug absorption, distribution, metabolism, and excretion, or with severe gastrointestinal diseases, dysphagia, or recurrent vomiting that causes difficulty in eating or taking medication.
- •Intolerance to the run-in period.
- •Poor medication compliance or other non-compliance during run-in period.
- •Participated in any interventional clinical trial within 3 months prior to screening, plan to participate in another clinical trial during the period of this trial, or plan to participate in another clinical trial within 1 month after the end of this trial.
- •History of alcohol abuse within 6 months prior to screening or evidence of drug abuse.
- •Not agree or unable to comply with the restrictions on concomitant treatment during the study.
- •Pregnancy test positive, lactating women, or women planning to become pregnant.
- •High-altitude workers or large motor vehicle drivers and other professionals engaged in hazardous mechanical operations.
- •Other conditions that by the investigator's discretion may interfere with efficacy or safety assessment of the study, or pose a great risk to the subject.
研究组 & 干预措施
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.
干预措施: QR12000 75mg (Drug)
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.
干预措施: QR12000 150mg placebo (Drug)
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.
干预措施: Sacubitril/valsartan 200mg placebo (Drug)
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.
干预措施: QR12000 75mg placebo (Drug)
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.
干预措施: QR12000 150mg (Drug)
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.
干预措施: Sacubitril/valsartan 200mg placebo (Drug)
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.
干预措施: QR12000 75mg placebo (Drug)
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.
干预措施: QR12000 150mg placebo (Drug)
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.
干预措施: Sacubitril/valsartan 200mg (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline and week 8
The change in msSBP measured at Week 8 relative to baseline.
次要结局
- 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)