RecruitingNot Applicable

Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

South Korea1,500 participantsStarted 2025-08-13

Plain-language summary

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).

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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
✓. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
✓. Patients who provided consent to participate in the study(informed consent form)

Exclusion criteria

✕. Contraindications in accordance with domestic prescribing information
✕. Patients participating in clinical trials of other investigational drugs
✕. Patients who do not provide consent to participate in the study

What they're measuring

Incidences of adverse events/adverse drug reactions (AEs/ADRs)

Timeframe: up to 15 months

Trial details

NCT IDNCT06770543

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-01-02

Contact for this trial

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

View on ClinicalTrials.gov More Primary Hypercholesterolemia or Mixed Dyslipidemia trials