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A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
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）.
Details
| Lead sponsor | Nanjing Yoko Biomedical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 262 |
| Start date | 2020-07-27 |
| Completion | 2021-12 |
Conditions
- Hypertensive Emergency
Interventions
- Clevidipine Butyrate Injection
- Ncardipine Hydrochloride Injection
Primary outcomes
- 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.
Countries
China