Clinical Study of Clevidipine Butyrate Injection in the Treatment of Hypertensive Emergency and Sub-emergency

NCT05044364 | Unknown Phase 3

• 1 other identifier: Cevidipine Butyrate Injection
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Emergency treatment warning of clevidipine butyrate butyrate injection or invalid medical treatment and verification of the effectiveness and safety of subacute.

Conditions

Hypertensive Emergency

Outcome Measures

Primary Outcomes (1)

• The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.

  The percentage of patients whose systolic blood pressure dropped to the target range within 30 minutes of starting the infusion.

  30 minutes

Study Arms (2)

China clevidipine butyrate injection

EXPERIMENTAL

Yangtze River Pharmaceutical Group Co., Ltd.

Drug: This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test.

Original research clevidipine butyrate injection

ACTIVE COMPARATOR

Fresenius Kabi Austria Gmb H (Austria)

Drug: This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test.

Interventions

This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test. DRUG

Patients with hypertensive emergency and hypertensive sub-emergency who are clinically diagnosed as unsuitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective, and require intravenous medication to quickly control their blood pressure. The qualified subjects will be randomly divided into groups according to the test protocol. The method of administration is to infuse clevidipine butyrate injection for emergency blood pressure reduction treatment to achieve rapid, effective and stable lowering of blood pressure to the target blood pressure, and prevent or reduce further damage to the target organ.

China clevidipine butyrate injection; Original research clevidipine butyrate 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:

• years old ≤ age ≤ 75 years old, men and women are not restricted;
• Hypertensive emergency and hypertensive sub-emergency patients who are not suitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective and require intravenous medication to quickly control blood pressure, and meet one of the following conditions: ① Consultation systolic blood pressure (SBP)\> Patients with 180mmHg and/or consulting room diastolic blood pressure (DBP)\> 120mmHg, with or without target organ damage;
• ②Patients whose blood pressure is moderately elevated at the time of consultation, although SBP\>180mmHg and/or DBP\>120mmHg have not reached SBP\>180mmHg and/or DBP\>120mmHg, but the investigator has judged patients with indications for venous hypotension;
• To participate in this clinical trial voluntarily, the subject (or legal representative) signs an informed consent form.

You may not qualify if:

• Those who cannot receive intravenous infusion of antihypertensive drugs for 18 hours or more;
• Patients with severe lipid metabolism abnormalities (such as triglycerides\> 5mmol/L, familial hypercholesterolemia, lipid nephropathy, or acute pancreatitis accompanied by hyperlipidemia);
• Patients who are known to have severe liver insufficiency or a history of liver failure or cirrhosis;
• Patients who are known to be intolerant or allergic to study drugs or calcium channel blockers, or are allergic to the ingredients of study drug excipients, or are allergic to soybeans, soy products, eggs and egg products;
• Patients with known or suspected severe aortic stenosis;
• Those with a clear history of secondary hypertension (including: pheochromocytoma, primary aldosteronism, etc.);
• Patients with known or suspected aortic dissection;
• Those with a history of drug or alcohol abuse, and those with acute hypertension caused by drug overdose;
• Pregnant or lactating women or patients who wish to have children during the trial period;
• Patients who have participated in clinical trials of other drugs or devices in the past 30 days;
• Patients who the investigator thinks are not suitable to participate in this trial.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (2)

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

MeSH Terms

Conditions

Hypertensive Crisis

Interventions

Single-Blind Method

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• DONG SHAOHONG, 59

  Shenzhen People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIN XIAOHUI, 34

CONTACT

18645005162; 517026400@163.com

Study Design

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

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: October 11, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 10, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)