UnknownPhase 3

A Study of Clevidipine Butyrate Injectable Emulsion in the Treatment of Hypertensive Emergency and Sub-emergency

398 participantsStarted 2023-05-01

Plain-language summary

A randomized, double-blind, active-compared phase Ш clinical trial to evaluate clevidipine butyrate injectable emulsion 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;
✓. Patients with hypertensive emergency and sub-emergency requiring a rapid intravenous blood-pressure control: patients with SBP \> 180 mmHg and/or DBP \> 120 mmHg (requiring twice consecutive blood pressure measurements, 10 to 15 min apart), with or without target organ damage;
✓. A potentially fertile patient is willing and required to use reliable contraceptive methods throughout the study period and for at least 3 months after initiation of test drug to avoid pregnancy in the female patient or in the male patient's partner;
✓. Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

Exclusion criteria

✕. Antihypertensive drugs have been used within 2 hours before the administration of test drugs;
✕. Patients with life-threatening clinical manifestations, such as malignant arrhythmias, respiratory failure, and severe disturbance of consciousness;
✕. Patients with confirmed or suspected severe aortic stenosis or aortic dissection at screening time;
✕. Patients with obstructive hypertrophic cardiomyopathy and systolic heart failure at screening time;
✕. Patients with acute coronary syndrome at screening or myocardial infarction within 1 month before screening;
✕. Patients with acute stroke within 1 month before screening;
✕. Patients with clear history of secondary hypertension;
✕. Patients with lipid metabolism defects;

What they're measuring

Proportion of patients whose SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration

Timeframe: 30 minutes

Trial details

NCT IDNCT05783557

SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-01

Contact for this trial

Clinical Trials Information Group officer

86-0311-69085587 ctr-contact@mail.cspc.cn

View on ClinicalTrials.gov More Hypertensive Emergency trials