Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

NCT ID: NCT04670809

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2021-12-31

Brief Summary

The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies（defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg, accompanied by acute organ damage）.

Conditions

Hypertensive Emergency

Study Design

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

Study Groups

Clevidipine Butyrate Injection

Group Type: EXPERIMENTAL

Clevidipine Butyrate Injection

Intervention Type: DRUG

Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.

Ncardipine Hydrochloride Injection

Group Type: ACTIVE_COMPARATOR

Ncardipine Hydrochloride Injection

Intervention Type: DRUG

Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.

Interventions

Clevidipine Butyrate Injection

Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.

Intervention Type: DRUG

Ncardipine Hydrochloride Injection

Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75, regardless of gender.

2. Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:

• Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms;
• Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
• Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;

3. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria

1. Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;

2. Patients with severe aortic stenosis or severe mitral stenosis;

3. Patients with obstructive hypertrophic cardiomyopathy;

4. Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;

5. Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;

6. Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;

7. Combined with other serious organ injury or serious complications which may affect the life of the subjects;

8. Patients with a history of mental illness;

9. Patients with known history of alcohol / drug abuse;

10. Those who have participated in other clinical trials and used test drugs 3 months before the trial;

11. Pregnant and lactating women;

12. Researchers do not consider it appropriate to participate in the clinical trial.

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

Sponsors

Nanjing Yoko Biomedical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital，Capital Medical University

Beijing, , China

Site Status: ACTIVE_NOT_RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yiran Ge

Role: CONTACT

Phone: 15298359892

Email: geyiran@yoko-bio.com

Facility Contacts

Guo, professor

Role: primary

Other Identifiers

NJYK-LVDP-III

Identifier Type: -

Identifier Source: org_study_id