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

NCT ID: NCT05922436

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-05-25

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

Conditions

Hypertensive Emergency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QLG2071

QLG2071 25mg: 50ml

Group Type: EXPERIMENTAL

QLG2071

Intervention Type: DRUG

intravenous injection

Cleviprex®

Cleviprex® 25mg: 50ml

Group Type: ACTIVE_COMPARATOR

Cleviprex®

Intervention Type: DRUG

intravenous injection

Interventions

QLG2071

intravenous injection

Intervention Type: DRUG

Cleviprex®

intravenous injection

Intervention Type: DRUG

Other Intervention Names

Clevidipine Butyrate Injectable Emulsion; Clevidipine Butyrate Injectable Emulsion

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical (Hainan) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuguo Chen

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

Yuguo Chen

Role: CONTACT

chen919085@126.com

0531-82169022

Other Identifiers

QLG2071-301

Identifier Type: -

Identifier Source: org_study_id