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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
398
intravenous injection
intravenous injection
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
Time frame: 30 minutes
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
Time frame: 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
Time frame: 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
Time frame: 6 hours
Change of heart rate from baseline within 30 min of administration
Change of heart rate from baseline within 30 min of administration
Time frame: 30 minutes
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Time frame: Throughout the study period, within 72 hours
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Total dosage of clevidipine butyrate injectable emulsion
Total dosage of clevidipine butyrate injectable emulsion
Time frame: Throughout the study period, within 72 hours