a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

Study Overview
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Brief Summary
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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

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 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

Conditions
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Hypertensive Emergency

Intervention / Treatment
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* Drug: QLG2071
* 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; 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. Exclusion Criteria: 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;

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: QLG2071<br>QLG2071 25mg: 50ml | Drug: QLG2071<br>* intravenous injection<br>* Other names: Clevidipine Butyrate Injectable Emulsion;|
| Active Comparator: Cleviprex®<br>Cleviprex® 25mg: 50ml | 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 |
| --- | --- | --- |
| the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration | Proportion of patients who reach the target range within 30 minutes of administration | Within 30 minutes of the initiation of the infusion | 

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 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 | Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation | within 6 hours of discontinuation | 
| Change in heart rate | Change of heart rate from baseline within 30 min of administration | within 30 minutes of administration | 
| Time to attainment of the 30-minute SBP target range | Time to attainment of the 30-minute SBP target range | within 30 minutes of administration |