Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies (NCT04670809) | Clinical Trial Compass
UnknownPhase 3
Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies
China262 participantsStarted 2020-07-27
Plain-language 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）.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✓. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.
Exclusion criteria
✕. 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;