search
Back to results

a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

Primary Purpose

Hypertensive Emergency

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
QLG2071
Cleviprex®
Sponsored by
Qilu Pharmaceutical (Hainan) 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; Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline; Able to understand informed consent, participate in the experiment voluntarily and sign informed consent. Exclusion Criteria: Patients with known severe lipid metabolism disorders; Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent; Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent; Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment; Patients with clear history of secondary hypertension; Patients with other serious large organ damage or serious complications, it may threaten life; Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients; Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs; Patients who cannot tolerate intravenous infusion therapy for at least 6 hours; Pregnant and lactating women or patients who plan to have a family during the trial period; Patients who have participated in other interventional clinical trials within 3 months prior to screening;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    QLG2071

    Cleviprex®

    Arm Description

    QLG2071 25mg: 50ml

    Cleviprex® 25mg: 50ml

    Outcomes

    Primary Outcome Measures

    the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
    Proportion of patients who reach the target range 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 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 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 in heart rate
    Change of heart rate from baseline within 30 min of administration
    Time to attainment of the 30-minute SBP target range
    Time to attainment of the 30-minute SBP target range

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 24, 2023
    Sponsor
    Qilu Pharmaceutical (Hainan) Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05922436
    Brief Title
    a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency
    Official Title
    A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the Efficacy and Safety of Intravenous QLG2071 Versus Cleviprex® for Patients With Hypertensive Emergency and Sub-emergency
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 15, 2023 (Anticipated)
    Primary Completion Date
    May 24, 2024 (Anticipated)
    Study Completion Date
    May 25, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Qilu Pharmaceutical (Hainan) Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® 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
    378 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    QLG2071
    Arm Type
    Experimental
    Arm Description
    QLG2071 25mg: 50ml
    Arm Title
    Cleviprex®
    Arm Type
    Active Comparator
    Arm Description
    Cleviprex® 25mg: 50ml
    Intervention Type
    Drug
    Intervention Name(s)
    QLG2071
    Other Intervention Name(s)
    Clevidipine Butyrate Injectable Emulsion
    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
    the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
    Description
    Proportion of patients who reach the target range within 30 minutes of administration
    Time Frame
    Within 30 minutes of the initiation of the infusion
    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 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 administration
    Time Frame
    Within 30 minutes of the initiation of the infusion
    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
    within 6 hours of discontinuation
    Title
    Change in heart rate
    Description
    Change of heart rate from baseline within 30 min of administration
    Time Frame
    within 30 minutes of administration
    Title
    Time to attainment of the 30-minute SBP target range
    Description
    Time to attainment of the 30-minute SBP target range
    Time Frame
    within 30 minutes of administration
    Other Pre-specified Outcome Measures:
    Title
    Incidence of adverse events (AEs)
    Description
    Incidence of adverse events (AEs)
    Time Frame
    Throughout the study period,up to 4 days

    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; Systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg assessed on two successive occasions, 15 minutes apart at baseline; Able to understand informed consent, participate in the experiment voluntarily and sign informed consent. Exclusion Criteria: Patients with known severe lipid metabolism disorders; Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent; Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent; Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment; Patients with clear history of secondary hypertension; Patients with other serious large organ damage or serious complications, it may threaten life; Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients; Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs; Patients who cannot tolerate intravenous infusion therapy for at least 6 hours; Pregnant and lactating women or patients who plan to have a family during the trial period; Patients who have participated in other interventional clinical trials within 3 months prior to screening;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuguo Chen
    Phone
    0531-82169022
    Email
    chen919085@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yuguo Chen
    Organizational Affiliation
    Qilu Hospital of Shandong University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

    We'll reach out to this number within 24 hrs