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

Hypertensive Emergency Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05922436
• Other study ID #: QLG2071-301
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 15, 2023
• Est. completion date: May 25, 2024

Study information

• Verified date: June 2023
• Source: Qilu Pharmaceutical (Hainan) Co., Ltd.
• Contact: Yuguo Chen
• Phone: 0531-82169022
• Email: chen919085[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 378
• Est. completion date: May 25, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Emergencies
• Hypertension, Malignant
• Hypertensive Emergency

Intervention

Drug:
• QLG2071
intravenous injection
• Cleviprex®
intravenous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical (Hainan) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events (AEs)	Incidence of adverse events (AEs)	Throughout the study period,up to 4 days
Primary	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	Within 30 minutes of the initiation of the infusion
Secondary	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	Within 30 minutes of the initiation of the infusion
Secondary	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	within 6 hours of discontinuation
Secondary	Change in heart rate	Change of heart rate from baseline within 30 min of administration	within 30 minutes of administration
Secondary	Time to attainment of the 30-minute SBP target range	Time to attainment of the 30-minute SBP target range	within 30 minutes of administration