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

Hypertensive Emergency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783557
• Other study ID #: HC1902-002
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2023
• Source: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
• Contact: Clinical Trials Information Group officer
• Phone: 86-0311-69085587
• Email: ctr-contact[@]mail.cspc.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 398
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Hypertension, Malignant
• Hypertensive Emergency

Intervention

Drug:
• Clevidipine Butyrate Injectable Emulsion
intravenous injection
• Cleviprex®
intravenous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change of heart rate from baseline within 30 min of administration	Change of heart rate from baseline within 30 min of administration	30 minutes
Secondary	Incidence of adverse events (AEs)	Incidence of adverse events (AEs)	Throughout the study period, within 72 hours
Secondary	Total dosage of clevidipine butyrate injectable emulsion	Total dosage of clevidipine butyrate injectable emulsion	Throughout the study period, within 72 hours