search
Back to results

To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

Primary Purpose

Primary Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Livalo, Ezetrol
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with primary hypercholesterolemia

Exclusion Criteria:

  • The subject not meet the specified LDL-C level

Sites / Locations

  • Gangdong Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Livalo 2mg, Ezetrol 10mg

Livalo 2mg

Livalo 4mg, Ezetrol 10mg

Livalo 4mg

Arm Description

Pitavastatin 2mg, Ezetimibe 10mg

Pitavastatin 2mg

Pitavastatin 4mg, Ezetimibe 10mg

Pitavastatin 4mg

Outcomes

Primary Outcome Measures

% change in LDL-C level from baseline at Week 8
change in LDL-C level

Secondary Outcome Measures

Change in LDL-C level from baseline at Week 4 and Week 8
change in LDL-C level

Full Information

First Posted
October 6, 2020
Last Updated
November 29, 2021
Sponsor
JW Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT04584736
Brief Title
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Official Title
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
July 16, 2020 (Actual)
Study Completion Date
October 12, 2020 (Actual)

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
No

5. Study Description

Brief Summary
To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
Detailed Description
A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Livalo 2mg, Ezetrol 10mg
Arm Type
Experimental
Arm Description
Pitavastatin 2mg, Ezetimibe 10mg
Arm Title
Livalo 2mg
Arm Type
Active Comparator
Arm Description
Pitavastatin 2mg
Arm Title
Livalo 4mg, Ezetrol 10mg
Arm Type
Experimental
Arm Description
Pitavastatin 4mg, Ezetimibe 10mg
Arm Title
Livalo 4mg
Arm Type
Active Comparator
Arm Description
Pitavastatin 4mg
Intervention Type
Drug
Intervention Name(s)
Livalo, Ezetrol
Other Intervention Name(s)
Pitavastatin, Ezetimibe
Intervention Description
Pitavastatin+Ezetimibe Pitavastatin
Primary Outcome Measure Information:
Title
% change in LDL-C level from baseline at Week 8
Description
change in LDL-C level
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Change in LDL-C level from baseline at Week 4 and Week 8
Description
change in LDL-C level
Time Frame
Week 4 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with primary hypercholesterolemia Exclusion Criteria: The subject not meet the specified LDL-C level
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dongryeong lee, Manager
Organizational Affiliation
+82-2-840-6982
Official's Role
Study Chair
Facility Information:
Facility Name
Gangdong Sacred Heart Hospital
City
Seoul
State/Province
Korea
ZIP/Postal Code
134-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36241463
Citation
Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.
Results Reference
derived

Learn more about this trial

To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia

We'll reach out to this number within 24 hrs