NCT05922436

a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® 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	QLG2071	intravenous injection
DRUG	Cleviprex®	intravenous injection

Timeline

• Start date: 2023-07-15
• Primary completion: 2024-05-24
• Completion: 2024-05-25
• First posted: 2023-06-28
• Last updated: 2023-06-28

Regulatory

• FDA-regulated drug study