To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

Korábbi kezelés

• long-term use of anticoagulants or antiplatelet drugs, including aspirin at any dose, due to treatment;
• currently using, or within 30 days before dosing or expected to use any drug or other component known to affect blood pressure during the study;
• any cardiovascular event within 6 months prior to screening

Más betegség

• secondary hypertension: kidney disease, endocrine disease, cardiovascular disease and moderate to severe obstructive sleep apnea without CPAP treatment;
• Grade 3 hypertension (severe): mean AOBP sitting SBP ≥ 180 mmHg, and/or DBP ≥ 110 mmHg; mean ABPM SBP > 160 mmHg, and/or mean DBP ≥ 100 mmHg;
• Patients with a history of hypertensive emergencies, or hypertensive sub-emergencies who have severe hypertension with headache, chest tightness, irritability, and epistaxis;
• high risk of bleeding or abnormal relevant indicators;
• unstable heart disease, such as uncontrolled symptomatic arrhythmia, atrial fibrillation, heart failure NYHA ≥ III, severe left ventricular hypertrophy, or a history of valvular heart disease;
• 12-lead ECG showed significant abnormal heart rate, arrhythmia or myocardial ischemia;

Laborértékek

• Type 2 diabetes with substandard blood glucose control: fasting blood glucose > 7.8 mmol/L, or 2-hour postprandial blood glucose/random blood glucose > 10.0 mmol/L, or HbA1c > 7%;
• echocardiography revealed heart failure:LVEF< 50%; abnormal ventricular diastolic function

• men or women ≥ 18 years of age and ≤ 65 years of age;
• patients with essential hypertension who are not receiving drug therapy or are receiving stable monotherapy (stable therapy: no change in antihypertensive drugs and doses within 30 days before screening);
• AOBP mean sitting SBP ≥ 140 and < 180 mmHg (at least 5 minutes rest before measurement, 3 measurements averaged over at least 1 minute apart) and mean SBP ≥ 130 and ≤ 160 mmHg at 24 hours ABPM;