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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: Lipilou®(generic atorvastatin drug) 10 mg; Drug: Lipilou®(generic atorvastatin drug) 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511000

124HL17003

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Experimental group

Experimental group

Treatment:

Drug: Lipilou®(generic atorvastatin drug) 20 mg

Comparator group

Active Comparator group

Treatment:

Drug: Lipilou®(generic atorvastatin drug) 10 mg