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

NCT ID: NCT06643130

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-02

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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JW0104+C2402

JW0104+C2402, 8 weeks, QD (Quaque Die)

Group Type EXPERIMENTAL

JW0104+C2402

Intervention Type DRUG

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

JW0104+C2403

JW0104+C2403, 8 weeks, QD

Group Type ACTIVE_COMPARATOR

JW0104+C2403

Intervention Type DRUG

For 8 weeks(PO, QD)

C2402

C2402, 8 weeks, QD

Group Type ACTIVE_COMPARATOR

C2402

Intervention Type DRUG

For 8 weeks(PO, QD)

Interventions

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JW0104+C2402

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

Intervention Type DRUG

JW0104+C2403

For 8 weeks(PO, QD)

Intervention Type DRUG

C2402

For 8 weeks(PO, QD)

Intervention Type DRUG

Other Intervention Names

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NA (Not Applicable) NA (Not Applicable) NA (Not Applicable)

Eligibility Criteria

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Inclusion Criteria

* Patients with hypertension and dyslipidemia

Exclusion Criteria

* The subject not meet the specified msBP and LDL-C level
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minjung Kim

Role: STUDY_CHAIR

JW Pharmaceutical

Locations

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Gangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Minjung Kim

Role: CONTACT

+82-2-840-6861

Dongryung Lee

Role: CONTACT

+82-2-840-6982

Facility Contacts

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Minjung Kim

Role: primary

+82-2-840-6861

Other Identifiers

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JW24301

Identifier Type: -

Identifier Source: org_study_id

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