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

April 14, 2021 updated by: JW Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

28343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving Livalo tablets in clinical practice in South Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 8 weeks after administration of pitavastatin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 8 weeks after administration of pitavastatin
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
At screening and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Sung-Rae Kim, MD,PhD, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2012

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JWP-PTV-712

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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