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

Qilu Pharmaceutical (Hainan) Co., Ltd.0 sites378 target enrollmentJuly 15, 2023

ConditionsHypertensive Emergency

InterventionsQLG2071 Cleviprex®

DrugsQLG2071 Cleviprex®

Overview

Phase: Phase 3
Intervention: QLG2071
Conditions: Hypertensive Emergency
Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Enrollment: 378
Primary Endpoint: the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

July 15, 2023

End Date

May 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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;

Arms & Interventions

QLG2071

QLG2071 25mg: 50ml

Intervention: QLG2071

Cleviprex®

Cleviprex® 25mg: 50ml

Intervention: Cleviprex®

Outcomes

Primary Outcomes

the percentage of patients who reach the target range (Systolic Blood Pressure 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 who reach the target range within 30 minutes of administration

Secondary Outcomes

Time to attainment of the 30-minute SBP target range(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(within 6 hours of discontinuation)
Change in heart rate(within 30 minutes of administration)