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Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Sponsor: Novartis Pharmaceuticals
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).
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2025-08-13
Completion Date
2031-01-02
Last Updated
2025-12-22
Healthy Volunteers
No
Interventions
Inclisiran
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)
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Taegu, South Korea