To Evaluate the Efficacy and Safety of KN060 in Essential Hypertension

Официальное название

Randomized, Single-blind, Placebo-controlled Exploratory Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety, Tolerability of KN060 in Patients With Essential Hypertension

Обзор

The primary objective of this study is to compare the change from baseline in systolic blood pressure between KN060 and placebo in patients with essential hypertension over 12 weeks; the secondary objectives are to assess the safety and tolerability of KN060 and to assess the pharmacokinetic and pharmacodynamic properties and immunogenicity of KN060 in patients with essential hypertension. The main questions it aims to answer are: * To verify the efficacy of KN060 in patients with essential hypertension * Safety of KN060 in Subjects Treated for Essential Hypertension Researchers will compare KN060 to placebo (0.9% sodium chloride 100ml) to assess the antihypertensive effect of KN060. Subjects will : * Receive KN060 or placebo by intravenous drip every two weeks for 6 doses. * AOBP, 24hABPM, HBPM,and safety were monitored and recorded.

Вмешательства

• Препарат KN060
  The dose was calculated based on the fasting body weight of the subject D1, and the corresponding volume of KN060 was drawn and added to 0.9% sodium chloride injection to prepare a 100 ml solution by intravenous drip every two weeks
• Препарат 0.9% Sodium Chloride Injection
  0.9% sodium chloride 100ml was administered as placebo by intravenous drip every two weeks

Первичные конечные точки

• Mean Systolic Blood Pressure (SBP) Change From Baseline in 24hABPM Adding KN060 or Placebo for 12 Weeks [Срок оценки: KN060 or placebo for 12 weeks]

Вторичные конечные точки (1)

• Proportion of subjects achieving target blood pressure control, incidence of adverse events, pharmacokinetic, pharmacodynamic and immunogenicity characteristics of KN060 in patients with essential hypertension [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;
• 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;
• 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%;
• any cardiovascular event within 6 months prior to screening
• 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;
• echocardiography revealed heart failure:LVEF< 50%; abnormal ventricular diastolic function

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07191899 · KN060-D-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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