Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Novartis Pharmaceuticals
1,500 participants
Aug 13, 2025
OBSERVATIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- If a subject meets all of the following criteria, he/she can participate in this study:
- 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 Criteria4
- A subjects who meets any of the following criteria cannot participate in this study:
- 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
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Interventions
There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06770543