NCT06770543

Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Primary Hypercholesterolemia or Mixed Dyslipidemia

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-08-13
• Primary completion: 2031-01-02
• Completion: 2031-01-02
• First posted: 2025-01-13
• Last updated: 2025-12-22

Locations

4 sites across 1 country: South Korea