Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg
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)
1 other identifier
interventional
250
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2017
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2019
CompletedFirst Submitted
Initial submission to the registry
August 9, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedAugust 12, 2020
August 1, 2020
1.6 years
August 9, 2020
August 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change rate in LDL-C
compare experimental group with comparator group
12 weeks of treatment
Study Arms (2)
Experimental group
EXPERIMENTALComparator group
ACTIVE COMPARATORInterventions
Patients assigned to experimental group are treated with Lipilou® 20 mg
Patients assigned to comparator group are treated with Lipilou® 10 mg
Eligibility Criteria
You may qualify if:
- Patients who had hypercholesterolemia with high risk, according to the 2015 Korean guidelines for managing dyslipidemia.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Korea University Ansan Hospital
Ansan, South Korea
Sejong General Hospital
Bucheon-si, South Korea
Dong-A University Hospital
Busan, South Korea
Inje University Ilsan Paik Hospital
Goyang, South Korea
Myongji Hospital
Goyang, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Korea University Guro Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2020
First Posted
August 12, 2020
Study Start
October 11, 2017
Primary Completion
May 20, 2019
Study Completion
May 20, 2019
Last Updated
August 12, 2020
Record last verified: 2020-08