NCT05044364

Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency

A Randomized, Single-blind, Positive Drug Parallel Controlled, Multi-center Clinical Study on the Efficacy and Safety of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.

Detailed description

The goal of the research and research is 18 weeks ≤ years of age, age ≤ 75 years of age, males are not limited; thoughtful for patients who are not suitable for taking medications or treating oral medications and need to quickly control blood sugar in emergency and hypertension sub-emergency patients, who meet the following conditions One: ① Clinic systolic pressure (SBP)\>180mmHg and/or clinic diastolic pressure (DBP)\>120mmHg, with or without target organ damage; ②The degree of increase at the time of consultation did not reach SBP\>180mmHg and or DBP\> Patients with 180mmHg and or DBP\>180mmHg but with indications of intravenous infusion of menstrual blood. According to the inflation method specified in the test protocol, clevidipine butyrate injection was infused for more urgent treatment to achieve rapid, effective, and slow reduction of blood sugar to the target blood sugar to prevent or start further organ damage.

Conditions

• Hypertensive Emergency

Interventions

Type	Name	Description
DRUG	This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test.	Patients with hypertensive emergency and hypertensive sub-emergency who are clinically diagnosed as unsuitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective, and require intravenous medication to quickly control their blood pressure. The qualified subjects will be randomly divided into groups according to the test protocol. The method of administration is to infuse clevidipine butyrate injection for emergency blood pressure reduction treatment to achieve rapid, effective and stable lowering of blood pressure to the target blood pressure, and prevent or reduce further damage to the target organ.

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-04-01
• Completion: 2022-10-10
• First posted: 2021-09-14
• Last updated: 2021-09-14

Locations

2 sites across 1 country: China