A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

NCT ID: NCT05783557

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-06-01

Brief Summary

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.

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

Experimental Group

Experimental Group

Group Type: EXPERIMENTAL

Clevidipine Butyrate Injectable Emulsion

Intervention Type: DRUG

intravenous injection

Active-compared Group

Active-compared Group

Group Type: ACTIVE_COMPARATOR

Cleviprex®

Intervention Type: DRUG

intravenous injection

Interventions

Clevidipine Butyrate Injectable Emulsion

intravenous injection

Intervention Type: DRUG

Cleviprex®

intravenous injection

Intervention Type: DRUG

Other Intervention Names

HC1902; Clevidipine Butyrate Injectable Emulsion

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years-old and ≤75 years-old, regardless of gender;

2. Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage;

3. A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner;

4. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion Criteria

1. Antihypertensive drugs have been used within 2 hours before the administration of test drugs;

2. Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness;

3. Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time;

4. Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time;

5. Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening;

6. Patients with acute stroke within 1 month before screening;

7. Patients with clear history of secondary hypertension;

8. Patients with lipid metabolism defects;

9. Patients with a known history of liver failure or cirrhosis;

10. Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment;

11. Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products;

12. Patients with mental illness, mental disorder and other disorders who cannot communicate properly;

13. A history of drug abuse, drug use, or alcohol dependence;

14. Female patients who are pregnant or lactating;

15. Patients who have participated in other interventional clinical trials within 3 months prior to screening;

16. Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.

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

Sponsors

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Changsheng Ma

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hosipital, Capital Medical University

Central Contacts

Clinical Trials Information Group officer

Role: CONTACT

ctr-contact@mail.cspc.cn

86-0311-69085587

Other Identifiers

HC1902-002

Identifier Type: -

Identifier Source: org_study_id