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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Emergency
• Intervention / Treatment: Drug: Clevidipine Butyrate Injectable Emulsion; Drug: Cleviprex®

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 (Anticipated): 398
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@mail.cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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: Experimental Group	Drug: Clevidipine Butyrate Injectable Emulsion; intravenous injection; Other Names: HC1902
Active Comparator: Active-compared Group	Drug: Cleviprex®; intravenous injection; Other Names: Clevidipine Butyrate Injectable Emulsion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration	Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration	30 minutes

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 30minutes min of 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 within 30 minutes of administration	30 minutes
AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration	AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration	1 hour
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	6 hours
Change of heart rate from baseline within 30 min of administration	Change of heart rate from baseline within 30 min of administration	30 minutes
Incidence of adverse events (AEs)	Incidence of adverse events (AEs)	Throughout the study period, within 72 hours
Total dosage of clevidipine butyrate injectable emulsion	Total dosage of clevidipine butyrate injectable emulsion	Throughout the study period, within 72 hours

Collaborators and Investigators

• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
• Investigators: Principal Investigator: Changsheng Ma, Beijing Anzhen Hosipital, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 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: HC1902-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No