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Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lipilou®(generic atorvastatin drug) 20 mg
Lipilou®(generic atorvastatin drug) 10 mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.

Exclusion Criteria:

  • Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction.
  • Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.

Sites / Locations

  • Korea University Ansan Hospital
  • Sejong General Hospital
  • Dong-A University Hospital
  • Inje University Ilsan Paik Hospital
  • Myongji Hospital
  • Seoul National University Bundang Hospital
  • Korea University Guro Hospital
  • Ulsan University Hospital
  • Wonju Severance Christian Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Comparator group

Arm Description

Outcomes

Primary Outcome Measures

Change rate in LDL-C
compare experimental group with comparator group

Secondary Outcome Measures

Full Information

First Posted
August 9, 2020
Last Updated
August 10, 2020
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04511000
Brief Title
Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg
Official Title
A Randomized, Open-label, Parallel, Multi-Center Phase IV Study to Compare of the Efficacy and Safety of Lipilou 20 mg and Lipilou 10 mg in High-risk Patients With Hypercholesterolemia(PEARL Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
May 20, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang 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
This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Comparator group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lipilou®(generic atorvastatin drug) 20 mg
Intervention Description
Patients assigned to experimental group are treated with Lipilou® 20 mg
Intervention Type
Drug
Intervention Name(s)
Lipilou®(generic atorvastatin drug) 10 mg
Intervention Description
Patients assigned to comparator group are treated with Lipilou® 10 mg
Primary Outcome Measure Information:
Title
Change rate in LDL-C
Description
compare experimental group with comparator group
Time Frame
12 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia. Exclusion Criteria: Patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction. Patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Sejong General Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg

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