Efficacy and Safety of Pitavastatin in a Real-world Setting

NCT04402112 | Completed FDA Drug

• 1 other identifier: JWP-PTV-712
• Study Type: observational
• Target: 28,343
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypercholesterolemia

Keywords

Pitavastatin; LIVALO; Safety data; South Korea; Large-scale prospective trial

Outcome Measures

Primary Outcomes (1)

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

  Incidence of musculoskeletal-related adverse events and rhabdomyolysis

  At 8 weeks after administration of pitavastatin

Secondary Outcomes (2)

• Overall symptom satisfaction evaluation

  At 8 weeks after administration of pitavastatin

• Change in serum lipid profile before and after administration of pitavastatin

  At screening and after 8 weeks

Interventions

Pitavastatin DRUG

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

Also known as: LIVALO

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving Livalo tablets in clinical practice in South Korea

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Related Publications (1)

• Jeong IK, Kim SR. Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study). Endocrinol Metab (Seoul). 2020 Dec;35(4):882-891. doi: 10.3803/EnM.2020.723. Epub 2020 Dec 2.

  PMID: 33261312 RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

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

Study Officials

• Sung-Rae Kim, MD,PhD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: May 26, 2020
• Study Start: April 2, 2012
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share