NCT06643130

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
162

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

October 9, 2024

Last Update Submit

September 2, 2025

Conditions

HypertensionDyslipidemia

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • change from baseline in msSBP

    week 4

  • Change and percent change from baseline in LDL-C

    week 4

Study Arms (3)

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

JW0104+C2402DRUG

For 8 weeks(PO (Per Oral), QD)

Also known as: NA (Not Applicable)
JW0104+C2402
JW0104+C2403DRUG

For 8 weeks(PO, QD)

Also known as: NA (Not Applicable)
JW0104+C2403
C2402DRUG

For 8 weeks(PO, QD)

Also known as: NA (Not Applicable)
C2402

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertension and dyslipidemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangdong Sacred Heart Hospital

Seoul, 05355, South Korea

RECRUITING

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

Sodium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Minjung Kim

    JW Pharmaceutical

    STUDY CHAIR

Central Study Contacts

Minjung Kim

CONTACT

+82-2-840-6861kmj@jwhealthcare.com

Dongryung Lee

CONTACT

+82-2-840-6982dongryung.lee@jwhealthcare.com

Study Design

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

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 16, 2024

Study Start

December 2, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-09

Locations

KR(1)