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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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