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Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

Primary Purpose

Hypertensive Emergency

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Clevidipine Butyrate Injection
Ncardipine Hydrochloride Injection
Sponsored by
Nanjing Yoko Biomedical Co., Ltd.
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. Age ≥ 18 and ≤ 75, regardless of gender.

  2. Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:

    • Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms;
    • Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
    • Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;
  3. The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

  1. Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;
  2. Patients with severe aortic stenosis or severe mitral stenosis;
  3. Patients with obstructive hypertrophic cardiomyopathy;
  4. Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;
  5. Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
  6. Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
  7. Combined with other serious organ injury or serious complications which may affect the life of the subjects;
  8. Patients with a history of mental illness;
  9. Patients with known history of alcohol / drug abuse;
  10. Those who have participated in other clinical trials and used test drugs 3 months before the trial;
  11. Pregnant and lactating women;
  12. Researchers do not consider it appropriate to participate in the clinical trial.

Sites / Locations

  • Beijing Anzhen Hospital，Capital Medical University
  • Beijing Chao-Yang Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clevidipine Butyrate Injection

Ncardipine Hydrochloride Injection

Arm Description

Outcomes

Primary Outcome Measures

Target reaching rate within 30 min
Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.

Secondary Outcome Measures

Mean time of target reaching
Mean time for subjects to reach target systolic blood pressure.
Rate of successful conversion to oral antihypertensive drugs
Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration.

Full Information

First Posted
December 11, 2020
Last Updated
December 15, 2020
Sponsor
Nanjing Yoko Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04670809
Brief Title
Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies
Official Title
A Randomized, Single Blind, Positive Parallel Controlled, Multicenter, Phase III Clinical Trial of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergencies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Yoko Biomedical Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies（defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg, accompanied by acute 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
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clevidipine Butyrate Injection
Arm Type
Experimental
Arm Title
Ncardipine Hydrochloride Injection
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clevidipine Butyrate Injection
Intervention Description
Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
Intervention Type
Drug
Intervention Name(s)
Ncardipine Hydrochloride Injection
Intervention Description
Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
Primary Outcome Measure Information:
Title
Target reaching rate within 30 min
Description
Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Mean time of target reaching
Description
Mean time for subjects to reach target systolic blood pressure.
Time Frame
Procedure (whole infusion duration)
Title
Rate of successful conversion to oral antihypertensive drugs
Description
Proportion of subjects who successfully converted to oral antihypertensive drugs within 6 hours after intravenous administration.
Time Frame
6 hours after intravenous administration

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: Age ≥ 18 and ≤ 75, regardless of gender. Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed: Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms; Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms; Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency; The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form. Exclusion Criteria: Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention; Patients with severe aortic stenosis or severe mitral stenosis; Patients with obstructive hypertrophic cardiomyopathy; Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study; Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products; Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia; Combined with other serious organ injury or serious complications which may affect the life of the subjects; Patients with a history of mental illness; Patients with known history of alcohol / drug abuse; Those who have participated in other clinical trials and used test drugs 3 months before the trial; Pregnant and lactating women; Researchers do not consider it appropriate to participate in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiran Ge
Phone
15298359892
Email
geyiran@yoko-bio.com
Facility Information:
Facility Name
Beijing Anzhen Hospital，Capital Medical University
City
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo, professor
Phone
13910039007
Email
shubinguo@126.com

12. IPD Sharing Statement

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Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

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