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Clinical Trials/NCT06643130
NCT06643130
Recruiting
Phase 3

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

JW Pharmaceutical1 site in 1 country162 target enrollmentDecember 2, 2024

Overview

Phase
Phase 3
Intervention
JW0104+C2402
Conditions
Hypertension
Sponsor
JW Pharmaceutical
Enrollment
162
Locations
1
Primary Endpoint
Change from baseline in msSBP (Systolic Blood Pressure)
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2024
End Date
April 1, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
JW Pharmaceutical
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with hypertension and dyslipidemia

Exclusion Criteria

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

Arms & Interventions

JW0104+C2402

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

Intervention: JW0104+C2402

JW0104+C2403

JW0104+C2403, 8 weeks, QD

Intervention: JW0104+C2403

C2402

C2402, 8 weeks, QD

Intervention: C2402

Outcomes

Primary Outcomes

Change from baseline in msSBP (Systolic Blood Pressure)

Time Frame: week 8

Check msSBP

Percent change from baseline in LDL-C (Low-Density Lipoprotein Cholesterol)

Time Frame: week 8

Check LDL-C

Secondary Outcomes

  • change from baseline in msSBP(week 4)
  • Change and percent change from baseline in LDL-C(week 4)

Study Sites (1)

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