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

This study was designed to compare the mean percent change of LDL-C between Lipilou® 10mg and 20mg group after 12 weeks of treatment.

Completed

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipilou®(generic atorvastatin drug) 20 mg

Drug

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

Lipilou®(generic atorvastatin drug) 10 mg

Drug

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

Primary outcomes

Change rate in LDL-C

Time frame: 12 weeks of treatment

compare experimental group with comparator group

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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)

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Aug 12, 2020
Registry last updated: Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed