NCT04670809Unknown3 期
A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
Nanjing Yoko Biomedical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2020年7月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Target reaching rate within 30 min
研究概览
简要总结
The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies（defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg, accompanied by acute organ damage）.
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
- Single (Participant)
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
- •Age ≥ 18 and ≤ 75, regardless of gender.
- •Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:
- •Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms;
- •Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
- •Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;
- •The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.
排除标准
- •Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;
- •Patients with severe aortic stenosis or severe mitral stenosis;
- •Patients with obstructive hypertrophic cardiomyopathy;
- •Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;
- •Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
- •Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
- •Combined with other serious organ injury or serious complications which may affect the life of the subjects;
- •Patients with a history of mental illness;
- •Patients with known history of alcohol / drug abuse;
- •Those who have participated in other clinical trials and used test drugs 3 months before the trial;
- •Pregnant and lactating women;
- •Researchers do not consider it appropriate to participate in the clinical trial.
研究组 & 干预措施
Clevidipine Butyrate Injection
Experimental
干预措施: Clevidipine Butyrate Injection (Drug)
Ncardipine Hydrochloride Injection
Active Comparator
干预措施: Ncardipine Hydrochloride Injection (Drug)
结局指标
主要结局
Target reaching rate within 30 min
时间窗: 30 min
Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.
次要结局
- Mean time of target reaching(Procedure (whole infusion duration))
- Rate of successful conversion to oral antihypertensive drugs(6 hours after intravenous administration)
研究者
研究点 (2)
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