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NCT05922436 | NOT YET RECRUITING | Hypertensive Emergency

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

Qilu Pharmaceutical (Hainan) Co., Ltd.

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

Condition or disease

Hypertensive Emergency

Intervention/treatment

QLG2071

Cleviprex®

Phase

PHASE3

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 378 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-07-15
Estimated Primary Completion Date : 2024-05-24
Estimated Study Completion Date : 2024-05-25

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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;
a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

Location Details

NCT05922436

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