UnknownPhase 3

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

378 participantsStarted 2023-07-15

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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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;

What they're measuring

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

Trial details

NCT IDNCT05922436

SponsorQilu Pharmaceutical (Hainan) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-24

Contact for this trial

Yuguo Chen

0531-82169022 chen919085@126.com

View on ClinicalTrials.gov More Hypertensive Emergency trials