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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Emergency
• Intervention / Treatment: Drug: Cleviprex®; Drug: QLG2071

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

• Study Type: Interventional
• Enrollment (Estimated): 378
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuguo Chen; Phone Number: 0531-82169022; Email: chen919085@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years-old and ≤75 years-old, regardless of gender;
2. Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
3. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion Criteria:

1. Patients with known severe lipid metabolism disorders;
2. 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;
3. Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
4. Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
5. Patients with clear history of secondary hypertension;
6. Patients with other serious large organ damage or serious complications, it may threaten life;
7. 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;
8. Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
9. Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
10. Pregnant and lactating women or patients who plan to have a family during the trial period;
11. Patients who have participated in other interventional clinical trials within 3 months prior to screening;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLG2071; QLG2071 25mg: 50ml	Drug: QLG2071; intravenous injection; Other Names: Clevidipine Butyrate Injectable Emulsion
Active Comparator: Cleviprex®; Cleviprex® 25mg: 50ml	Drug: Cleviprex®; intravenous injection; Other Names: Clevidipine Butyrate Injectable Emulsion

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Incidence of adverse events (AEs)	Throughout the study period,up to 4 days

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
• Investigators: Principal Investigator: Yuguo Chen, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): May 24, 2024
• Study Completion (Estimated): May 25, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies; Hypertension, Malignant; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: QLG2071-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes