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

Sponsor
JW Pharmaceutical (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05331014
Collaborator
(none)
144
Enrollment
1
Location
3
Arms
16.5
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect [week 8]

      change in msSBP and LDL-C level

    Secondary Outcome Measures

    1. efficacy and safety [week 8]

      change in msSBP and LDL-C level

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with hypertension and dyslipidemia
    Exclusion Criteria:
    • The subject not meet the specified msBP and LDL-C level

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangdong Sacred Heart Hospital Seoul Korea Korea, Republic of 134-701

    Sponsors and Collaborators

    • JW Pharmaceutical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JW Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT05331014
    Other Study ID Numbers:
    • JWP-PVA-301
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Dyslipidemias

    Study Results

    No Results Posted as of Apr 15, 2022