NCT05922436尚未招募3 期
A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 378
- 主要终点
- the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
研究概览
简要总结
A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® in the Treatment of Hypertensive Emergency and Sub-emergency
详细描述
This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug
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
- Triple (Participant, Care Provider, Investigator)
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 years-old and ≤75 years-old, regardless of gender;
- •Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
- •Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.
排除标准
- •Patients with known severe lipid metabolism disorders;
- •Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent;
- •Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
- •Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
- •Patients with clear history of secondary hypertension;
- •Patients with other serious large organ damage or serious complications, it may threaten life;
- •Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients;
- •Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
- •Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
- •Pregnant and lactating women or patients who plan to have a family during the trial period;
- •Patients who have participated in other interventional clinical trials within 3 months prior to screening;
研究组 & 干预措施
QLG2071
Experimental
QLG2071 25mg: 50ml
干预措施: QLG2071 (Drug)
Cleviprex®
Active Comparator
Cleviprex® 25mg: 50ml
干预措施: Cleviprex® (Drug)
结局指标
主要结局
the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
时间窗: Within 30 minutes of the initiation of the infusion
Proportion of patients who reach the target range within 30 minutes of administration
次要结局
- Time to attainment of the 30-minute SBP target range(within 30 minutes of administration)
- The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration(Within 30 minutes of the initiation of the infusion)
- Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation(within 6 hours of discontinuation)
- Change in heart rate(within 30 minutes of administration)
研究者
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