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Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Recruitingn/aAges 18 Years - 100 YearsAllNovartis Pharmaceuticals
NCT06770543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This non-interventional study is a mandatory regular Post Marketing Surveillance(rPMS) granted by the Korean health authorities, and is conducted to assess the effectiveness and safety of Leqvio® Pre-filled Syringe(inclisiran sodium) in routine clinical practice for the approved indications (primary hypercholesterolemia or mixed dyslipidemia).

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📋 Eligibility rules (as published)
Inclusion Criteria: If a subject meets all of the following criteria, he/she can participate in this study: 1. Adult patients(18 years or older) who have hypercholesterolemia or mixed dyslipidemia and are prescribed Leqvio® Pre-filled Syringe(inclisiran sodium) according to domestically approved product information in real clinical practice 2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance 3. Patients who provided consent to participate in the study(informed consent form) Exclusion Criteria: A subjects who meets any of the following criteria cannot participate in this study: 1. Contraindications in accordance with domestic prescribing information 2. Patients participating in clinical trials of other investigational drugs 3. Patients who do not provide consent to participate in the study
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What it tests

  • Inclisiran
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Where

4 sites
Novartis Investigative Site
Yangsan, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Taegu, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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