NCT04670809

Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Nanjing Yoko Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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）.

Conditions

• Hypertensive Emergency

Interventions

Type	Name	Description
DRUG	Clevidipine 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.
DRUG	Ncardipine 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.

Timeline

• Start date: 2020-07-27
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2020-12-17
• Last updated: 2020-12-17

Locations

2 sites across 1 country: China