Efficacy and Safety of Pitavastatin in a Real-world Setting

Hypercholesterolemia Clinical Trial

— PROOF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402112
• Other study ID #: JWP-PTV-712
• Status: Completed
• Start date: April 2, 2012
• Est. completion date: August 1, 2017

Study information

• Verified date: April 2021
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28343
• Est. completion date: August 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Pitavastatin
1mg, 2mg, or 4mg, Once a day, at least 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

References & 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. — View Citation

Outcome

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