A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

Study Overview
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Brief Summary
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A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind, Active-compared Phase Ш Clinical Trial to Evaluate Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

Conditions
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Hypertensive Emergency

Intervention / Treatment
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* Drug: Clevidipine Butyrate Injectable Emulsion
* Drug: Cleviprex®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years-old and ≤75 years-old, regardless of gender; Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage; A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner; Able to understand informed consent, participate in the experiment voluntarily and sign informed consent. Exclusion Criteria: Antihypertensive drugs have been used within 2 hours before the administration of test drugs; Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness; Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time; Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time; Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening; Patients with acute stroke within 1 month before screening; Patients with clear history of secondary hypertension; Patients with lipid metabolism defects; Patients with a known history of liver failure or cirrhosis; Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment; Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products; Patients with mental illness, mental disorder and other disorders who cannot communicate properly; A history of drug abuse, drug use, or alcohol dependence; Female patients who are pregnant or lactating; Patients who have participated in other interventional clinical trials within 3 months prior to screening; Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Experimental Group | Drug: Clevidipine Butyrate Injectable Emulsion<br>* intravenous injection<br>* Other names: HC1902;|
| Active Comparator: Active-compared Group<br>Active-compared Group | Drug: Cleviprex®<br>* intravenous injection<br>* Other names: Clevidipine Butyrate Injectable Emulsion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration | Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of 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 within 30 minutes of administration | 30 minutes | 
| AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration | AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration | 1 hour | 
| Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation | Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation | 6 hours | 
| Change of heart rate from baseline within 30 min of administration | Change of heart rate from baseline within 30 min of administration | 30 minutes | 
| Incidence of adverse events (AEs) | Incidence of adverse events (AEs) | Throughout the study period, within 72 hours | 
| Total dosage of clevidipine butyrate injectable emulsion | Total dosage of clevidipine butyrate injectable emulsion | Throughout the study period, within 72 hours |