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NCT04511000 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04511000
Other study ID # 124HL17003
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 11, 2017
Est. completion date May 20, 2019

Study information
Verified date August 2020
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date May 20, 2019
Est. primary completion date May 20, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lipilou®(generic atorvastatin drug) 20 mg
Patients assigned to experimental group are treated with Lipilou® 20 mg
• Lipilou®(generic atorvastatin drug) 10 mg
Patients assigned to comparator group are treated with Lipilou® 10 mg

Locations
Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Sejong General Hospital Bucheon
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Ilsan Paik Hospital Goyang
Korea, Republic of Myongji Hospital Goyang
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Ulsan University Hospital Ulsan
Korea, Republic of Wonju Severance Christian Hospital Wonju
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change rate in LDL-C compare experimental group with comparator group 12 weeks of treatment
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