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
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
378
intravenous injection
intravenous injection
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
Time frame: Within 30 minutes of the initiation of the infusion
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
Time frame: 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
Time frame: within 6 hours of discontinuation
Change in heart rate
Change of heart rate from baseline within 30 min of administration
Time frame: 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
Time frame: within 30 minutes of administration
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