Clinical trial NCT04670809: Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies
Official title: A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertensive Emergency
Lead sponsor: Nanjing Yoko Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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）.


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.

Primary outcomes:
measure: Target reaching rate within 30 min
timeFrame: 30 min
Secondary outcomes:
measure: Mean time of target reaching
timeFrame: Procedure (whole infusion duration)
measure: Rate of successful conversion to oral antihypertensive drugs
timeFrame: 6 hours after intravenous administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital，Capital Medical University
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
Study officials:
References: