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A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

Primary Purpose

Hypertensive Emergency

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Clevidipine Butyrate Injectable Emulsion
Cleviprex®
Sponsored by
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) 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: Age ≥18 years-old and ≤75 years-old, regardless of gender; Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage; A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner; Able to understand informed consent, participate in the experiment voluntarily and sign informed consent. Exclusion Criteria: Antihypertensive drugs have been used within 2 hours before the administration of test drugs; Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness; Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time; Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time; Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening; Patients with acute stroke within 1 month before screening; Patients with clear history of secondary hypertension; Patients with lipid metabolism defects; Patients with a known history of liver failure or cirrhosis; Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment; Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products; Patients with mental illness, mental disorder and other disorders who cannot communicate properly; A history of drug abuse, drug use, or alcohol dependence; Female patients who are pregnant or lactating; Patients who have participated in other interventional clinical trials within 3 months prior to screening; Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental Group

    Active-compared Group

    Arm Description

    Experimental Group

    Active-compared Group

    Outcomes

    Primary Outcome Measures

    Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
    Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration

    Secondary Outcome Measures

    The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of within 30 minutes of administration
    The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of within 30 minutes of administration
    AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
    AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
    Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
    Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
    Change of heart rate from baseline within 30 min of administration
    Change of heart rate from baseline within 30 min of administration
    Incidence of adverse events (AEs)
    Incidence of adverse events (AEs)
    Total dosage of clevidipine butyrate injectable emulsion
    Total dosage of clevidipine butyrate injectable emulsion

    Full Information

    First Posted
    March 13, 2023
    Last Updated
    March 13, 2023
    Sponsor
    CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05783557
    Brief Title
    A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
    Official Title
    A Randomized, Double-blind, Active-compared Phase Ш Clinical Trial to Evaluate Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    4. Oversight

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

    5. Study Description

    Brief Summary
    A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion 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.

    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
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    398 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    Experimental Group
    Arm Title
    Active-compared Group
    Arm Type
    Active Comparator
    Arm Description
    Active-compared Group
    Intervention Type
    Drug
    Intervention Name(s)
    Clevidipine Butyrate Injectable Emulsion
    Other Intervention Name(s)
    HC1902
    Intervention Description
    intravenous injection
    Intervention Type
    Drug
    Intervention Name(s)
    Cleviprex®
    Other Intervention Name(s)
    Clevidipine Butyrate Injectable Emulsion
    Intervention Description
    intravenous injection
    Primary Outcome Measure Information:
    Title
    Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
    Description
    Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of within 30 minutes of administration
    Description
    The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of within 30 minutes of administration
    Time Frame
    30 minutes
    Title
    AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
    Description
    AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration
    Time Frame
    1 hour
    Title
    Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
    Description
    Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
    Time Frame
    6 hours
    Title
    Change of heart rate from baseline within 30 min of administration
    Description
    Change of heart rate from baseline within 30 min of administration
    Time Frame
    30 minutes
    Title
    Incidence of adverse events (AEs)
    Description
    Incidence of adverse events (AEs)
    Time Frame
    Throughout the study period, within 72 hours
    Title
    Total dosage of clevidipine butyrate injectable emulsion
    Description
    Total dosage of clevidipine butyrate injectable emulsion
    Time Frame
    Throughout the study period, within 72 hours

    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 years-old and ≤75 years-old, regardless of gender; Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP > 180 mmHg and/or DBP > 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage; A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner; Able to understand informed consent, participate in the experiment voluntarily and sign informed consent. Exclusion Criteria: Antihypertensive drugs have been used within 2 hours before the administration of test drugs; Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness; Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time; Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time; Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening; Patients with acute stroke within 1 month before screening; Patients with clear history of secondary hypertension; Patients with lipid metabolism defects; Patients with a known history of liver failure or cirrhosis; Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment; Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products; Patients with mental illness, mental disorder and other disorders who cannot communicate properly; A history of drug abuse, drug use, or alcohol dependence; Female patients who are pregnant or lactating; Patients who have participated in other interventional clinical trials within 3 months prior to screening; Patients who are judged by the investigators to be ineligible for this study for other factors, such as patients who could not receive intravenous infusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Clinical Trials Information Group officer
    Phone
    86-0311-69085587
    Email
    ctr-contact@mail.cspc.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changsheng Ma
    Organizational Affiliation
    Beijing Anzhen Hosipital, Capital Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

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