Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Phase 3

• Conditions: Hypertensive Emergency
• Interventions: Drug: Clevidipine Butyrate Injection; Drug: Ncardipine Hydrochloride Injection

• Registration Number: NCT04670809
• Lead Sponsor: Nanjing Yoko Biomedical Co., Ltd.

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）.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-27
• Status Verified: 2020-12
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-15
• Last Update Submitted: 2020-12-15
• Study First Posted: 2020-12-17
• Last Update Posted: 2020-12-17
• Primary Completion: 2021-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 262

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clevidipine Butyrate Injection	Clevidipine Butyrate Injection	-
Ncardipine Hydrochloride Injection	Ncardipine Hydrochloride Injection	-

Primary Outcome Measures

Name	Time	Method
Target reaching rate within 30 min	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.

Secondary Outcome Measures

Name	Time	Method
Mean time of target reaching	Procedure (whole infusion duration)	Mean time for subjects to reach target systolic blood pressure.
Rate of successful conversion to oral antihypertensive drugs	6 hours after intravenous administration	Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration.

Trial Locations

Locations (2)

Beijing Anzhen Hospital，Capital Medical University; 🇨🇳 Beijing, China

Beijing Chao-Yang Hospital, Capital Medical University; 🇨🇳 Beijing, China