To Evaluate the Efficacy and Safety in Patients With Dysl... | NCT05331014

Studies
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

NCT05331014

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

155Actual

Phase

Phase 3

Conditions

Dyslipidemia
Hypertension

Interventions

LivaloVA
LivaloV
VA

Countries

South Korea

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2021Actual

Primary Completion Date

Nov 8, 2022Actual

Completion Date

Nov 8, 2022Actual

First Submitted Date

Apr 4, 2022

First Submission Date that Met QC Criteria

Apr 10, 2022

First Posted Date

Apr 15, 2022Actual

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

Mar 14, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Multi-center, Randomized, Double-blind, Parallel, phase III Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Detailed Description

Multicenter, randomized, double-blind, parallel-design, phase III clinical study

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

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JW0101+C2101	Experimental	LivaloVA	Drug: LivaloVA
JW0101+C2102	Active Comparator	LivaloV	Drug: LivaloV
C2101	Active Comparator	VA	Drug: VA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LivaloVA	Drug	For 8 weeks(PO, QD)	JW0101+C2101	JW0101+C2101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect	change in msSBP and LDL-C level	week 8

Secondary Outcomes

Measure	Description	Time Frame
efficacy and safety	change in msSBP and LDL-C level	week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hypertension and dyslipidemia

Exclusion Criteria:

The subject not meet the specified msBP and LDL-C level

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gyurok Han, CI	Gangdong Sacred Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangdong Sacred Heart Hospital		Seoul	Korea	134-701	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias
D006973	Hypertension

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided