To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension

Phase 3

Completed

• Conditions: Dyslipidemia; Hypertension
• Interventions: Drug: VA; Drug: LivaloVA; Drug: LivaloV

• Registration Number: NCT05331014
• 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 JW0101+C2101 in Patients with Dyslipidemia and Hypertension.

Detailed Description

Multicenter, randomized, double-blind, parallel-design, phase III clinical study

Study Timeline

• Study Start: 2021-11-15
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-10
• Study First Posted: 2022-04-15
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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
C2101	VA	VA
JW0101+C2101	LivaloVA	LivaloVA
JW0101+C2102	LivaloV	LivaloV

Primary Outcome Measures

Name	Time	Method
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect	week 8	change in msSBP and LDL-C level

Secondary Outcome Measures

Name	Time	Method
efficacy and safety	week 8	change in msSBP and LDL-C level

Trial Locations

Locations (1)

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