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NCT05331014 Clinical Trial

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

Hypertension Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05331014
Other study ID # JWP-PVA-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 15, 2021
Est. completion date November 8, 2022

Study information
Verified date March 2024
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date November 8, 2022
Est. primary completion date November 8, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility Inclusion Criteria: - Patients with hypertension and dyslipidemia Exclusion Criteria: - The subject not meet the specified msBP and LDL-C level

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• LivaloVA
For 8 weeks(PO, QD)
• LivaloV
For 8 weeks(PO, QD)
• VA
For 8 weeks(PO, QD)

Locations
Country Name City State
Korea, Republic of Gangdong Sacred Heart Hospital Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect change in msSBP and LDL-C level week 8
Secondary efficacy and safety change in msSBP and LDL-C level week 8
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