a Study Evaluating the Safety and Efficacy of Clevidipine... | NCT05922436

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

NCT05922436

Sponsor

Qilu Pharmaceutical (Hainan) Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 28, 2023Actual

Enrollment

378Estimated

Phase

Phase 3

Conditions

Hypertensive Emergency

Interventions

QLG2071
Cleviprex®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2023Estimated

Primary Completion Date

May 24, 2024Estimated

Completion Date

May 25, 2024Estimated

First Submitted Date

Jun 12, 2023

First Submission Date that Met QC Criteria

Jun 24, 2023

First Posted Date

Jun 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2023

Last Update Posted Date

Jun 28, 2023Actual

Description Module

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

Detailed Description

This is a multicenter, randomized, double-blind, active-compared Phase III clinical study to evaluate the efficacy and safety of clevidipine butyrate injectable emulsion in the treatment of Hypertensive Emergency and Sub-emergency. The Cleviprex® will be chosen as the positive controlled medicine with the same usage of the test drug

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

378Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QLG2071	Experimental	QLG2071 25mg: 50ml	Drug: QLG2071
Cleviprex®	Active Comparator	Cleviprex® 25mg: 50ml	Drug: Cleviprex®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QLG2071	Drug	intravenous injection	QLG2071	Clevidipine Butyrate Injectable Emulsion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)	Incidence of adverse events (AEs)	Throughout the study period,up to 4 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases