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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04511000

Enrollment

250

Registered

2020-08-12

Start date

2017-10-11

Completion date

2019-05-20

Last updated

2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DRUGLipilou®(generic atorvastatin drug) 20 mg

Patients assigned to experimental group are treated with Lipilou® 20 mg

DRUGLipilou®(generic atorvastatin drug) 10 mg

Patients assigned to comparator group are treated with Lipilou® 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Change rate in LDL-C	12 weeks of treatment	compare experimental group with comparator group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026