a Study Evaluating the Safety and Efficacy of Clevidipine for Patients Who With Hypertensive Emergency and Sub-emergency

NCT05922436 | Unknown Phase 3 FDA Drug

• 1 other identifier: QLG2071-301
• Study Type: interventional
• Target: 378
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Multicentre, Randomized, Double-blind, Parallel Design Phase III Study to Evaluate the efficacy and safety of QLG2071 Versus Cleviprex® in the Treatment of Hypertensive Emergency and Sub-emergency

Conditions

Hypertensive Emergency

Outcome Measures

Primary Outcomes (1)

• the percentage of patients who reach the target range (Systolic Blood Pressure decreased by ≥15% and ≤25% from baseline) within 30 minutes of administration

  Proportion of patients who reach the target range within 30 minutes of administration

  Within 30 minutes of the initiation of the infusion

Secondary Outcomes (4)

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

  Within 30 minutes of the initiation of the infusion

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

  within 6 hours of discontinuation

• Change in heart rate

  within 30 minutes of administration

• Time to attainment of the 30-minute SBP target range

  within 30 minutes of administration

Other Outcomes (1)

• Incidence of adverse events (AEs)

  Throughout the study period,up to 4 days

Study Arms (2)

QLG2071

EXPERIMENTAL

QLG2071 25mg: 50ml

Drug: QLG2071

Cleviprex®

ACTIVE COMPARATOR

Cleviprex® 25mg: 50ml

Drug: Cleviprex®

Interventions

QLG2071 DRUG

intravenous injection

Also known as: Clevidipine Butyrate Injectable Emulsion

QLG2071

Cleviprex® DRUG

intravenous injection

Also known as: Clevidipine Butyrate Injectable Emulsion

Cleviprex®

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;
• Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg assessed on two successive occasions, 15 minutes apart at baseline；
• Able to understand informed consent, participate in the experiment voluntarily and sign informed consent.

You may not qualify if:

• Patients with known severe lipid metabolism disorders;
• Patients with severe acute cardiovascular disease, such as confirmed or suspected severe aortic stenosis or aortic dissection, aortic syndrome, severe mitral stenosis, obstructive hypertrophic cardiomyopathy, acute myocardial infarction, and patients who have had an acute myocardial infarction within 1 month prior to signing the written informed consent;
• Patients with acute ischemic/hemorrhagic stroke or cerebral hemorrhage within 1 month before signing the written informed consent;
• Patients with known history of liver failure or cirrhosis and chronic kidney disease stage 5 requiring long-term regular dialysis treatment;
• Patients with clear history of secondary hypertension;
• Patients with other serious large organ damage or serious complications, it may threaten life;
• Known intolerance to test drugs or calcium channel blockers; or who are allergic to soy, soy products, eggs, and egg products, or to experimental drug excipients;
• Intravenous antihypertensive drugs have been used within 2 hours before the administration of test drugs;
• Patients who cannot tolerate intravenous infusion therapy for at least 6 hours;
• Pregnant and lactating women or patients who plan to have a family during the trial period;
• Patients who have participated in other interventional clinical trials within 3 months prior to screening;

Sponsors & Collaborators

• Qilu Pharmaceutical (Hainan) Co., Ltd.: lead

MeSH Terms

Conditions

Hypertensive Crisis

Interventions

clevidipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yuguo Chen

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuguo Chen

CONTACT

0531-82169022; chen919085@126.com

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: June 12, 2023
• First Posted: June 28, 2023
• Study Start: July 15, 2023
• Primary Completion: May 24, 2024
• Study Completion: May 25, 2024
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share