Status:
UNKNOWN
Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies
Lead Sponsor:
Nanjing Yoko Biomedical Co., Ltd.
Conditions:
Hypertensive Emergency
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 \>...
Eligibility Criteria
Inclusion
- Age ≥ 18 and ≤ 75, regardless of gender.
- 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;
- The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.
Exclusion
- Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;
- Patients with severe aortic stenosis or severe mitral stenosis;
- Patients with obstructive hypertrophic cardiomyopathy;
- Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;
- 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;
- Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
- Combined with other serious organ injury or serious complications which may affect the life of the subjects;
- Patients with a history of mental illness;
- Patients with known history of alcohol / drug abuse;
- Those who have participated in other clinical trials and used test drugs 3 months before the trial;
- Pregnant and lactating women;
- Researchers do not consider it appropriate to participate in the clinical trial.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04670809
Start Date
July 27 2020
End Date
December 1 2021
Last Update
December 17 2020
Active Locations (2)
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1
Beijing Anzhen Hospital，Capital Medical University
Beijing, China
2
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China