Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Hypertensive Emergency Clinical Trial

Official title:

A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04670809
• Other study ID #: NJYK-LVDP-III
• Status: Recruiting
• Phase: Phase 3
• Start date: July 27, 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Nanjing Yoko Biomedical Co., Ltd.
• Contact: Yiran Ge
• Phone: 15298359892
• Email: geyiran[@]yoko-bio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Hypertension, Malignant
• Hypertensive Emergency

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital,Capital Medical University	Beijing
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Yoko Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target reaching rate within 30 min	Proportion of subjects whose systolic blood pressure dropped to the target range (decrease = 15% and = 25% from baseline) in the first 30 minutes of administration.	30 min
Secondary	Mean time of target reaching	Mean time for subjects to reach target systolic blood pressure.	Procedure (whole infusion duration)
Secondary	Rate of successful conversion to oral antihypertensive drugs	Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration.	6 hours after intravenous administration