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

September 2, 2025 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Seoul, South Korea, 05355
        • Recruiting
        • Gangdong Sacred Heart Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with hypertension and dyslipidemia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JW0104+C2402
JW0104+C2402, 8 weeks, QD (Quaque Die)
Drug: JW0104+C2402
For 8 weeks(PO (Per Oral), QD)
Other Names:
  • NA (Not Applicable)
Active Comparator: JW0104+C2403
JW0104+C2403, 8 weeks, QD
Drug: JW0104+C2403
For 8 weeks(PO, QD)
Other Names:
  • NA (Not Applicable)
Active Comparator: C2402
C2402, 8 weeks, QD
Drug: C2402
For 8 weeks(PO, QD)
Other Names:
  • NA (Not Applicable)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Study Chair: Minjung Kim, JW Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW24301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on JW0104+C2402

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe