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Recruiting

NCT Number: NCT07083206

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

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

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin-si, South Korea

Location status: Recruiting

Location contact

Deok Kyu Cho

CONTACT

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Rate of reaching the target LDL-C level

    Time frame: 12 months after administration

Study contacts

Contact information is provided by the study sponsor or research team.

Hyunji Kim

CONTACT

[email protected]

+82-2-3289-4215

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin Monotherapy

Acronym: PIVOTAL

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 24, 2025
Registry last updated
Aug 7, 2025

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.

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