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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertensive Emergency
• Intervention / Treatment: 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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: JIN XIAOHUI, 34; Phone Number: 18645005162; Email: 517026400@163.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518020
      • ShenZhen People's Hospital
    • Shenzhen, Guangdong, China, 518000
      • Shenzhen People' S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, men and women are not restricted;

2. Hypertensive emergency and hypertensive sub-emergency patients who are not suitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective and require intravenous medication to quickly control blood pressure, and meet one of the following conditions: ① Consultation systolic blood pressure (SBP)> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)> 120mmHg, with or without target organ damage;

   ②Patients whose blood pressure is moderately elevated at the time of consultation, although SBP>180mmHg and/or DBP>120mmHg have not reached SBP>180mmHg and/or DBP>120mmHg, but the investigator has judged patients with indications for venous hypotension;

3. To participate in this clinical trial voluntarily, the subject (or legal representative) signs an informed consent form.

Exclusion Criteria:

1. Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more;
2. Patients with severe lipid metabolism abnormalities (such as triglycerides> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia);
3. Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis;
4. Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or are allergic to the ingredients of study drug excipients, or are allergic to soybeans, soy products, eggs and egg products;
5. Patients with known or suspected severe aortic stenosis;
6. Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.);
7. Patients with known or suspected aortic dissection;
8. Those with a history of drug or alcohol abuse, and those with acute hypertension caused by drug overdose;
9. Pregnant or lactating women or patients who wish to have children during the trial period;
10. Patients who have participated in clinical trials of other drugs or devices in the past 30 days;
11. Patients who the investigator thinks are not suitable to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: China clevidipine butyrate injection; Yangtze River Pharmaceutical Group Co., Ltd.	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.
Active Comparator: Original research clevidipine butyrate injection; Fresenius Kabi Austria Gmb H (Austria)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.	The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.	30 minutes

Collaborators and Investigators

• Sponsor: Shenzhen People's Hospital
• Investigators: Principal Investigator: DONG SHAOHONG, 59, ShenZhen People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 11, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): October 10, 2022

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: September 5, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies; Hypertension, Malignant; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Clevidipine
• Other Study ID Numbers: Cevidipine Butyrate Injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No