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CompletedNCT05331014Updated Mar 15, 2024

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

A Phase 3 interventional study of LivaloVA and LivaloV in Dyslipidemia and Hypertension, sponsored by JW Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by JW Pharmaceutical · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2021, registered Apr 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
19 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Dyslipidemia
  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 155 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with hypertension and dyslipidemia

Exclusion criteria

Exclusion Criteria:

  • The subject not meet the specified msBP and LDL-C level
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
155 participants (actual)

Study arms

  • Experimental
    JW0101+C2101

    LivaloVA

    Drug: LivaloVA

  • Active comparator
    JW0101+C2102

    LivaloV

    Drug: LivaloV

  • Active comparator
    C2101

    VA

    Drug: VA

Interventions

  • DrugLivaloVA

    For 8 weeks(PO, QD)

    Also known as: JW0101+C2101

  • DrugLivaloV

    For 8 weeks(PO, QD)

    Also known as: JW0101+C2102

  • DrugVA

    For 8 weeks(PO, QD)

    Also known as: C2101

06

What researchers measure

Primary outcomes

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

    change in msSBP and LDL-C level

    Time frame: week 8

Secondary outcomes

  1. efficacy and safety

    change in msSBP and LDL-C level

    Time frame: week 8

07

Study locations

1 site
  • Gangdong Sacred Heart Hospital
    Seoul, Korea 134-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05331014
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Apr 15, 2022
Start date
Nov 15, 2021
Primary completion
Nov 8, 2022
Completion
Nov 8, 2022
Last update
Mar 15, 2024

Study contacts

Gyurok Han, CI
principal investigator · Gangdong Sacred Heart Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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