Back to resultsTo Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
Primary Purpose
Dyslipidemia, Hypertension
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LivaloVA
LivaloV
VA
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- Patients with hypertension and dyslipidemia
Exclusion Criteria:
- The subject not meet the specified msBP and LDL-C level
Sites / Locations
- Gangdong Sacred Heart HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
JW0101+C2101
JW0101+C2102
C2101
Arm Description
LivaloVA
LivaloV
VA
Outcomes
Primary Outcome Measures
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
change in msSBP and LDL-C level
Secondary Outcome Measures
efficacy and safety
change in msSBP and LDL-C level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05331014
Brief Title
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Multicenter, randomized, double-blind, parallel-design, phase III clinical study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JW0101+C2101
Arm Type
Experimental
Arm Description
LivaloVA
Arm Title
JW0101+C2102
Arm Type
Active Comparator
Arm Description
LivaloV
Arm Title
C2101
Arm Type
Active Comparator
Arm Description
VA
Intervention Type
Drug
Intervention Name(s)
LivaloVA
Other Intervention Name(s)
JW0101+C2101
Intervention Description
For 8 weeks(PO, QD)
Intervention Type
Drug
Intervention Name(s)
LivaloV
Other Intervention Name(s)
JW0101+C2102
Intervention Description
For 8 weeks(PO, QD)
Intervention Type
Drug
Intervention Name(s)
VA
Other Intervention Name(s)
C2101
Intervention Description
For 8 weeks(PO, QD)
Primary Outcome Measure Information:
Title
msSBP (8 weeks) lowering effect, LDL-C (8 weeks) lowering effect
Description
change in msSBP and LDL-C level
Time Frame
week 8
Secondary Outcome Measure Information:
Title
efficacy and safety
Description
change in msSBP and LDL-C level
Time Frame
week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with hypertension and dyslipidemia
Exclusion Criteria:
The subject not meet the specified msBP and LDL-C level
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inyoung Park, SM
Phone
+82-2-840-6887
Email
20190203@jw-group.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Dongryeong Lee, Manager
Phone
+82-2-840-6982
Email
dongryung.lee@jw-pharma.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyurok Han, CI
Organizational Affiliation
Gangdong Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangdong Sacred Heart Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
134-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyurok Han
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety in Patients With Dyslipidemia and Hypertension
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