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

March 14, 2024 updated by: JW Pharmaceutical

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 134-701
        • Gangdong Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with hypertension and dyslipidemia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JW0101+C2101
LivaloVA
Drug: LivaloVA
For 8 weeks(PO, QD)
Other Names:
  • JW0101+C2101
Active Comparator: JW0101+C2102
LivaloV
Drug: LivaloV
For 8 weeks(PO, QD)
Other Names:
  • JW0101+C2102
Active Comparator: C2101
VA
Drug: VA
For 8 weeks(PO, QD)
Other Names:
  • C2101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
Time Frame: week 8
change in msSBP and LDL-C level
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy and safety
Time Frame: week 8
change in msSBP and LDL-C level
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Gyurok Han, CI, Gangdong Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

November 8, 2022

Study Completion (Actual)

November 8, 2022

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 14, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-PVA-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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