NCT05331014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2022

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

April 4, 2022

Last Update Submit

March 14, 2024

Conditions

DyslipidemiaHypertension

Outcome Measures

Primary Outcomes (1)

  • msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect

    change in msSBP and LDL-C level

    week 8

Secondary Outcomes (1)

  • efficacy and safety

    week 8

Study Arms (3)

JW0101+C2101

EXPERIMENTAL

LivaloVA

Drug: LivaloVA

JW0101+C2102

ACTIVE COMPARATOR

LivaloV

Drug: LivaloV

C2101

ACTIVE COMPARATOR

VA

Drug: VA

Interventions

LivaloVADRUG

For 8 weeks(PO, QD)

Also known as: JW0101+C2101
JW0101+C2101
LivaloVDRUG

For 8 weeks(PO, QD)

Also known as: JW0101+C2102
JW0101+C2102
VADRUG

For 8 weeks(PO, QD)

Also known as: C2101
C2101

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertension and dyslipidemia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangdong Sacred Heart Hospital

Seoul, Korea, 134-701, South Korea

Location

MeSH Terms

Conditions

DyslipidemiasHypertension

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gyurok Han, CI

    Gangdong Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 15, 2022

Study Start

November 15, 2021

Primary Completion

November 8, 2022

Study Completion

November 8, 2022

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

KR(1)