Skip to content

Efficacy and safety of clevidipine butyrate injection in the treatment of hypertensive emergency and sub-emergency: a randomized, single-blind, positive drug parallel controlled, multi-center clinical study

Efficacy and safety of clevidipine butyrate injection in the treatment of hypertensive emergency and sub-emergency: a randomized, single-blind, positive drug parallel controlled, multi-center clinical study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050577
Enrollment
Unknown
Registered
2021-08-29
Start date
2021-09-30
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive emergency and sub-emergency

Interventions

test group:Domestic Clevidipine Butyrate Injection
Control group:Original Research Clevidipine Butyrate Injection

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Patients with hypertensive emergencies and hypertensive sub-emergency patients who are not suitable for oral antihypertensive drug treatment or who are ineffective in oral antihypertensive drug treatment and need intravenous medication to quickly control blood pressure, and meet one of the following conditions: (1) Patients with office systolic blood pressure (SBP)>180mmHg and/or office diastolic blood pressure (DBP)>120mmHg, with or without target organ damage; (2) Patients with moderately elevated blood pressure at the time of visit, although not reaching SBP>180mmHg and/or DBP>120mmHg, but there are indications for venous hypotension as judged by the investigator. 3. Voluntarily participate in this clinical trial, and the subjects (or legal representatives) sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more; 2. Patients with severe abnormal lipid metabolism (such as triglyceride>5mmol/L, familial hypercholesterolemia, lipoid nephropathy, or acute pancreatitis with hyperlipidemia); 3. Patients with known severe hepatic insufficiency or a history of liver failure or cirrhosis; 4. Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or allergic to study drug excipients, or allergic to soybeans, soy products, eggs and egg products; 5. Patients with known or suspected severe aortic stenosis; 6. Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.); 7. Patients with known or suspected aortic dissection; 8. Those with a history of drug or alcohol abuse, and those with acute hypertension due to drug overdose; 9. Pregnant, lactating women or patients who intend to have children during the trial; 10 Patients who have participated in clinical trials of other drugs or devices within the past 30 days; 11. Patients who are considered by the investigator to be inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Systolic blood pressure;

Countries

China

Contacts

Public ContactDong Xiaohong
dsh266@outlook.com+86 13509633742

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026