Safety and Efficacy Study of Clevidipine Butyrate Injection in Hypertensive Emergencies

NCT04670809 | Unknown Phase 3

• 1 other identifier: NJYK-LVDP-III
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study was to determine the efficacy and safety of clevidipine for treating Hypertensive emergencies（defined as systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg, accompanied by acute organ damage）.

Conditions

Hypertensive Emergency

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Mean time of target reaching

  Procedure (whole infusion duration)

• Rate of successful conversion to oral antihypertensive drugs

  6 hours after intravenous administration

Study Arms (2)

Clevidipine Butyrate Injection

EXPERIMENTAL

Drug: Clevidipine Butyrate Injection

Ncardipine Hydrochloride Injection

ACTIVE COMPARATOR

Drug: Ncardipine Hydrochloride Injection

Interventions

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.

Clevidipine Butyrate Injection

Ncardipine Hydrochloride Injection DRUG

Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added 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 6μg/(kg•min). 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.

Ncardipine Hydrochloride Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Yoko Biomedical Co., Ltd.: lead

Study Sites (2)

Beijing Anzhen Hospital，Capital Medical University

Beijing, China

ACTIVE NOT RECRUITING

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 41231022 DERIVED

MeSH Terms

Conditions

Hypertensive Crisis

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yiran Ge

CONTACT

15298359892; geyiran@yoko-bio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: July 27, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

CN (2)