Hypertensive Emergency
Conditions
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）.
Interventions
DRUGClevidipine 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.
DRUGNcardipine 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.
Sponsors
Nanjing Yoko Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYiran Ge
Outcome results
None listed