PROOF: Efficacy and Safety of Pitavastatin in a Real-world Setting

Sponsor

JW Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT04402112

Collaborator

(none)

28,343

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Drug: Pitavastatin

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 Design

Study Type:

Observational

Actual Enrollment :

28343 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Safety of Pitavastatin in a Real-wOrld Setting: Observational Study Evaluating saFety in Patient With Pitavastatin for Lipid Lowering Therapy in Korea

Actual Study Start Date :

Apr 2, 2012

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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