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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypertensive Emergency

Treatments: Drug: Cleviprex®; Drug: QLG2071

Study type: Interventional

Funder types: Industry

Identifiers

NCT05922436

QLG2071-301

Details and patient eligibility

About

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

Full 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

Enrollment: 378 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

378 participants in 2 patient groups

QLG2071

Experimental group

Description:

QLG2071 25mg: 50ml

Treatment:

Drug: QLG2071

Cleviprex®

Active Comparator group

Description:

Cleviprex® 25mg: 50ml

Treatment:

Drug: Cleviprex®