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

Phase 3

Not yet recruiting

• Conditions: Hypertension; Dyslipidemia
• Interventions: Drug: JW0104+C2402; Drug: JW0104+C2403; Drug: C2402

• Registration Number: NCT06643130
• Lead Sponsor: JW Pharmaceutical

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2024-11
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Patients with hypertension and dyslipidemia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JW0104+C2402	JW0104+C2402	JW0104+C2402, 8 weeks, QD (Quaque Die)
JW0104+C2403	JW0104+C2403	JW0104+C2403, 8 weeks, QD
C2402	C2402	C2402, 8 weeks, QD

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change from baseline in msSBP	week 4	Check msSBP
Change and percent change from baseline in LDL-C	week 4	Check LDL-C

Trial Locations

Locations (1)

Gangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of