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

NCT05783557 | Unknown Phase 3 DMC

• 1 other identifier: HC1902-002
• Study Type: interventional
• Target: 398
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertensive Emergency

Outcome Measures

Primary Outcomes (1)

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

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

  30 minutes

Secondary Outcomes (6)

• The time for the first SBP fell within the target range (SBP decreased by ≥15% and ≤25% from baseline) within 30minutes min of within 30 minutes of administration

  30 minutes

• AUC above the upper limit of the target range and below the lower limit of the target range within 1 hour of administration

  1 hour

• Proportion of patients successfully converted to oral antihypertensive therapy within 6 hours of discontinuation

  6 hours

• Change of heart rate from baseline within 30 min of administration

  30 minutes

• Incidence of adverse events (AEs)

  Throughout the study period, within 72 hours

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group

Drug: Clevidipine Butyrate Injectable Emulsion

Active-compared Group

ACTIVE COMPARATOR

Active-compared Group

Drug: Cleviprex®

Interventions

Clevidipine Butyrate Injectable Emulsion DRUG

intravenous injection

Also known as: HC1902

Experimental Group

Cleviprex® DRUG

intravenous injection

Also known as: Clevidipine Butyrate Injectable Emulsion

Active-compared Group

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 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.

You may not qualify if:

• 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;
• Patients with a known history of liver failure or cirrhosis;
• Patients with chronic kidney disease (CKD) stage 5, requiring long-term regular dialysis treatment;
• Patients who are allergic to the test drug or its ingredients, or who are intolerant to calcium channel blockers, or who are allergic to soy, soy products, eggs and egg products;
• Patients with mental illness, mental disorder and other disorders who cannot communicate properly;
• A history of drug abuse, drug use, or alcohol dependence;
• Female patients who are pregnant or lactating;
• Patients who have participated in other interventional clinical trials within 3 months prior to screening;

Sponsors & Collaborators

• CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.: lead

MeSH Terms

Conditions

Hypertensive Crisis

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Changsheng Ma

  Beijing Anzhen Hosipital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03