Evaluate the Efficacy and Safety of Co-administration of... | NCT06643130

Studies
Evaluate the Efficacy and Safety of Co-administration of JW0104+C2402 in Patients With Hypertension and Dyslipidemia

NCT06643130

Sponsor

JW Pharmaceutical

Status

Recruiting

Last Update Posted

Sep 9, 2025Actual

Enrollment

162Estimated

Phase

Phase 3

Conditions

Hypertension
Dyslipidemia

Interventions

JW0104+C2402
JW0104+C2403
C2402

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2024Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Oct 9, 2024

First Submission Date that Met QC Criteria

Oct 14, 2024

First Posted Date

Oct 16, 2024Actual

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

Sep 2, 2025

Last Update Posted Date

Sep 9, 2025Actual

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 JW0104+C2402 in Patients with Hypertension and Dyslipidemia

Detailed Description

To evaluate the efficacy and safety of co-administration of JW0104+C2402 in comparison with co-administration of JW0104+C2403 or C2402 alone in patients with hypertension and dyslipidemia.

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

162Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JW0104+C2402	Experimental	JW0104+C2402, 8 weeks, QD (Quaque Die)	Drug: JW0104+C2402
JW0104+C2403	Active Comparator	JW0104+C2403, 8 weeks, QD	Drug: JW0104+C2403
C2402	Active Comparator	C2402, 8 weeks, QD	Drug: C2402

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JW0104+C2402	Drug	For 8 weeks(PO (Per Oral), QD)	JW0104+C2402	NA (Not Applicable)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in msSBP (Systolic Blood Pressure)	Check msSBP	week 8
Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)	Check LDL-C	week 8

Secondary Outcomes

Measure	Description	Time Frame
change from baseline in msSBP	Check msSBP	week 4
Change and percent change from baseline in LDL-C	Check LDL-C	week 4

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

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Minjung Kim	Contact	+82-2-840-6861		kmj@jwhealthcare.com
Dongryung Lee	Contact	+82-2-840-6982		dongryung.lee@jwhealthcare.com

Overall Officials

Name	Affiliation	Role
Minjung Kim	JW Pharmaceutical	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gangdong Sacred Heart Hospital	Recruiting	Seoul		05355	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012964	Sodium

Ancestor Terms

ID	Term
D008672	Metals, Alkali
D004602	Elements
D007287	Inorganic Chemicals
D019565	Metals, Light

Browse Leaves

Not provided

Browse Branches

Not provided