Clinical trial NCT05922436: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertensive Emergency
Lead sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years-old and ≤75 years-old, regardless of gender;
2. Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
3. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion Criteria:

1. Patients with known severe lipid metabolism disorders;
2. 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;
3. Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
4. Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
5. Patients with clear history of secondary hypertension;
6. Patients with other serious large organ damage or serious complications, it may threaten life;
7. 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;
8. Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
9. Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
10. Pregnant and lactating women or patients who plan to have a family during the trial period;
11. Patients who have participated in other interventional clinical trials within 3 months prior to screening;

Primary outcomes:
measure: the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
timeFrame: Within 30 minutes of the initiation of the infusion
Secondary outcomes:
measure: The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration
timeFrame: Within 30 minutes of the initiation of the infusion
measure: Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation
timeFrame: within 6 hours of discontinuation
measure: Change in heart rate
timeFrame: within 30 minutes of administration
measure: Time to attainment of the 30-minute SBP target range
timeFrame: within 30 minutes of administration
Other outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Throughout the study period,up to 4 days
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yuguo Chen
role: PRINCIPAL_INVESTIGATOR
References: