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

Primary Purpose

Hypertensive Emergency

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
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.
Sponsored by
Shenzhen People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Emergency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen People' S Hospital
  • Shenzhen People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

China clevidipine butyrate injection

Original research clevidipine butyrate injection

Arm Description

Yangtze River Pharmaceutical Group Co., Ltd.

Fresenius Kabi Austria Gmb H (Austria)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2021
Last Updated
September 5, 2021
Sponsor
Shenzhen People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05044364
Brief Title
Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
October 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Emergency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
China clevidipine butyrate injection
Arm Type
Experimental
Arm Description
Yangtze River Pharmaceutical Group Co., Ltd.
Arm Title
Original research clevidipine butyrate injection
Arm Type
Active Comparator
Arm Description
Fresenius Kabi Austria Gmb H (Austria)
Intervention Type
Drug
Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.
Description
The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old ≤ age ≤ 75 years old, men and women are not restricted; 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; To participate in this clinical trial voluntarily, the subject (or legal representative) signs an informed consent form. Exclusion Criteria: Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more; Patients with severe lipid metabolism abnormalities (such as triglycerides> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia); Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis; 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; Patients with known or suspected severe aortic stenosis; Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.); Patients with known or suspected aortic dissection; Those with a history of drug or alcohol abuse, and those with acute hypertension caused by drug overdose; Pregnant or lactating women or patients who wish to have children during the trial period; Patients who have participated in clinical trials of other drugs or devices in the past 30 days; Patients who the investigator thinks are not suitable to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIN XIAOHUI, 34
Phone
18645005162
Email
517026400@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DONG SHAOHONG, 59
Organizational Affiliation
Shenzhen People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen People' S Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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