Skip to main content
OpenTrials
Completed

NCT Number: NCT04402112

Efficacy and Safety of Pitavastatin in a Real-world Setting

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pitavastatin

Drug

1mg, 2mg, or 4mg, Once a day, at least 8 weeks

Other names: LIVALO

Primary outcomes

  1. Number of participants with adverse events as assessed by CTCAE v4.0

    Time frame: At 8 weeks after administration of pitavastatin

    Incidence of musculoskeletal-related adverse events and rhabdomyolysis

Secondary outcomes

  1. Overall symptom satisfaction evaluation

    Time frame: At 8 weeks after administration of pitavastatin

    The investigating physician selects one of the followings according to medical judgment: Improvement, constant, exacerbation

  2. Change in serum lipid profile before and after administration of pitavastatin

    Time frame: At screening and after 8 weeks

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study 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

Acronym: PROOF

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
May 26, 2020
Registry last updated
Apr 19, 2021

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.

Related clinical trials

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