Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Nanjing Yoko Biomedical

Status and phase: Unknown; Phase 3

Conditions: Hypertensive Emergency

Treatments: Drug: Ncardipine Hydrochloride Injection; Drug: Clevidipine Butyrate Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04670809

NJYK-LVDP-III

Details and patient eligibility

About

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）.

Enrollment: 262 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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262 participants in 2 patient groups

Clevidipine Butyrate Injection

Experimental group

Treatment:

Drug: Clevidipine Butyrate Injection

Ncardipine Hydrochloride Injection

Active Comparator group

Treatment:

Drug: Ncardipine Hydrochloride Injection