Safety and Efficacy Study of Clevidipine Butyrate Injecti... | NCT04670809

NCT04670809

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clevidipine Butyrate Injection	Experimental		Drug: Clevidipine Butyrate Injection
Ncardipine Hydrochloride Injection	Active Comparator		Drug: Ncardipine Hydrochloride Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clevidipine Butyrate Injection	Drug	Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target reaching rate within 30 min	Proportion of subjects whose systolic blood pressure dropped to the target range (decrease ≥ 15% and ≤ 25% from baseline) in the first 30 minutes of administration.	30 min

Secondary Outcomes

Measure	Description	Time Frame
Mean time of target reaching	Mean time for subjects to reach target systolic blood pressure.	Procedure (whole infusion duration)
Rate of successful conversion to oral antihypertensive drugs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 and ≤ 75, regardless of gender.
Blood pressure increased seriously in a short time, systolic blood pressure (SBP) > 180 mmHg and (or) diastolic blood pressure (DBP) > 120 mmHg (measured at an interval of 5 minutes, both blood pressure values should be > 180 / 120 mmHg), accompanied with progressive target organ damages as below or evidences of other target organ damage can be confirmed:
- Hypertensive encephalopathy: headache, dizziness, irritability, nausea, vomiting, blurred vision and other symptoms;
- Acute left heart failure: dyspnea, pulmonary rales, edema and other symptoms;
- Unstable angina pectoris: ischemic chest pain with ST-T dynamic changes. Patients with SBP ≥ 220mmhg and / or DBP ≥ 140mmHg should be considered as hypertensive emergency;
The legal representative and / or patient agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

Patients with arterial dissection, acute hemorrhagic or ischemic stroke, and acute coronary syndrome in urgent need of surgical or emergency intervention;
Patients with severe aortic stenosis or severe mitral stenosis;
Patients with obstructive hypertrophic cardiomyopathy;
Patients who have used other intravenous antihypertensive drugs within 2 hours before entering this study;
Patients known to be intolerant or allergic to calcium channel blockers, or allergic to test drug ingredients, or allergic to soy / soy products or egg / egg products;
Patients with lipid metabolism defects, such as pathological hyperlipidemia, lipid nephropathy, or acute pancreatitis with hyperlipidemia;
Combined with other serious organ injury or serious complications which may affect the life of the subjects;
Patients with a history of mental illness;
Patients with known history of alcohol / drug abuse;
Those who have participated in other clinical trials and used test drugs 3 months before the trial;
Pregnant and lactating women;
Researchers do not consider it appropriate to participate in the clinical trial.

Name	Role	Phone	Extension	Email
Yiran Ge	Contact	15298359892		geyiran@yoko-bio.com

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Anzhen Hospital，Capital Medical University	Active, not recruiting	Beijing			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41231022	Derived	Lv Q, Chen C, Lin L, Zhao X, Chen J, Liang Z, Chai Y, Du B, Sun L, Chen X, Liu M, Zhang X, Cao Z, Zhang H, Chen D, Wang Z, Zhong Y, Zhu J, Gao F, Wang X, Zhang G, Li L, Ma J, Zhao M, Ouyang Y, Guo S, Wang H, Yang P, He R, Zhao Z, Sun L, Wu L, Wu Y, Liu X, Xu T, Li N, Zhu T, Ma C. Efficacy and safety of clevidipine emulsion injection compared with nicardipine in patients with hypertensive emergencies: a randomized, single-blind, positive-parallel-controlled, phase III clinical trial. J Hypertens. 2026 Jan 1;44(1):204-210. doi: 10.1097/HJH.0000000000004180. Epub 2025 Oct 23.