Efficacy and Safety of Pitavastatin in a Real-world Setting

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT04402112
• Lead Sponsor: JW Pharmaceutical

Brief Summary

The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin (Livalo) in clinical practice in 28,343 patients.

Detailed Description

This study was conducted in 893 facilities in Korea from 2 Apr 2012 to 1 Apr 2017. This study was designed to administer 1mg, 2mg, or 4mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.

Study Timeline

• Study Start: 2012-04-02
• Primary Completion: 2017-04-01
• Study Completion: 2017-08-01
• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28343

Inclusion Criteria

• Patients in need of statin treatment who are taking or are planning to take Livalo tablets, or who are taking other statins or are planning to change to Livalo tablets.

Exclusion Criteria

• Patients with hypersensitivity to pitavastatin
• Patients with active liver disease or untranslated transaminase levels Patients with a constant rise in
• Patients with severe liver failure or biliary obstruction and patients with cholestasis
• Patients who are receiving cyclosporine
• Myopathy patients
• Pregnant women or women of childbearing age and lactating women
• Children
• Patients with genetic problems, such as galactose intolerance, Lapp lactose deficiency or glucose-galactose
• Patients deemed inappropriate by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as assessed by CTCAE v4.0	At 8 weeks after administration of pitavastatin	Incidence of musculoskeletal-related adverse events and rhabdomyolysis

Secondary Outcome Measures

Name	Time	Method
Overall symptom satisfaction evaluation	At 8 weeks after administration of pitavastatin	The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation
Change in serum lipid profile before and after administration of pitavastatin	At screening and after 8 weeks	Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride