NCT05783557

A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

A Randomized, Double-blind, Active-compared Phase Ш Clinical Trial to Evaluate Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 398 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency.

Detailed description

This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug.

Conditions

• Hypertensive Emergency

Interventions

Type	Name	Description
DRUG	Clevidipine Butyrate Injectable Emulsion	intravenous injection
DRUG	Cleviprex®	intravenous injection

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-01
• Completion: 2025-06-01
• First posted: 2023-03-24
• Last updated: 2023-03-24