Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Study Overview
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Brief Summary
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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）.

Official Title
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A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies

Conditions
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Hypertensive Emergency

Intervention / Treatment
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* Drug: Clevidipine Butyrate Injection
* Drug: Ncardipine Hydrochloride Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clevidipine Butyrate Injection<br> | Drug: Clevidipine Butyrate Injection<br>* Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.<br>|
| Active Comparator: Ncardipine Hydrochloride Injection<br> | Drug: Ncardipine Hydrochloride Injection<br>* Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target reaching rate within 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. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time of target reaching | Mean time for subjects to reach target systolic blood pressure. | Procedure (whole infusion duration) | 
| Rate of successful conversion to oral antihypertensive drugs | Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration. | 6 hours after intravenous administration |