Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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）.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanjing Yoko Biomedical Co., Ltd.
• Treatments: Clevidipine

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.