A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe

NCT07083206 | Recruiting

• 1 other identifier: Pitaeze_OS
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effectiveness and safety of Pitavastatin/Ezetimibe FDC in patients with hypercholesterolemia.

Conditions

Hypercholesterolemia; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Rate of reaching the target LDL-C level

  12 months after administration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who require administration of a fixed-dose combination of pitavastatin/ezetimibe for the treatment of hypercholesterolemia

You may qualify if:

• Adults aged 19 years or older
• Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin/ezetimibe has been clinically decided
• Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr/eGFR) within 12 months prior to switching to fixed-dose combination pitavastatin/ezetimibe (no changes in statin regimen or dosage during that period)
• Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study

You may not qualify if:

• Known hypersensitivity or history of hypersensitivity to any component of the investigational product
• Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels
• Patients with severe hepatic impairment, biliary obstruction, or cholestasis
• Patients currently receiving cyclosporine treatment
• Patients diagnosed with myopathy
• Pregnant or breastfeeding women, or women who may be pregnant
• Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, South Korea

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Dyslipidemias

Condition Hierarchy (Ancestors)

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

Study Officials

• Deok Kyu Cho

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyunji Kim

CONTACT

+82-2-3289-4215; hyunji.kim@ahn-gook.com

Study Design

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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)