QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

Официальное название

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

Обзор

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.

Вмешательства

• Препарат QR12000 75mg
  QR12000 75mg QD
• Препарат QR12000 75mg placebo
  Matching placebo of QR12000 75mg QD
• Препарат QR12000 150mg
  QR12000 150mg QD
• Препарат QR12000 150mg placebo
  Matching placebo of QR12000 150mg QD
• Препарат Sacubitril/valsartan 200mg
  Sacubitril/valsartan 200mg QD
• Препарат Sacubitril/valsartan 200mg placebo
  Matching placebo of Sacubitril/valsartan 200mg QD

Первичные конечные точки

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [Срок оценки: Baseline and week 8]

Вторичные конечные точки (6)

• Change From Baseline in Mean Sitting Diastolic BP (msDBP) [Срок оценки: Baseline and week 8]
• Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) [Срок оценки: Baseline and week 8]
• Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP [Срок оценки: Baseline and week 8]
• Percentage of Participants Achieving BP Control [Срок оценки: Baseline and week 8]
• Percentage of Participants Achieving BP Response [Срок оценки: Baseline and week 8]
• Change From Baseline in msSBP/msDBP [Срок оценки: Baseline, week 28 and week 52]

Критерии участия

Критерии включения

• 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/m2.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Идентификаторы

NCT: NCT06716970 · QR12000-GXY-3-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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