Actively Recruiting
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Led by Novartis Pharmaceuticals · Updated on 2025-12-22
1500
Participants Needed
4
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years or older with hypercholesterolemia or mixed dyslipidemia prescribed Leqvio Pre-filled Syringe (inclisiran sodium) according to approved product information
- Patients unable to reach LDL-C target with maximum tolerated dose of statin, or with statin intolerance
- Patients who have provided informed consent to participate in the study
You will not qualify if you...
- Contraindications as per domestic prescribing information for Leqvio
- Patients currently participating in clinical trials of other investigational drugs
- Patients who do not provide consent to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, South Korea, 50612
Actively Recruiting
2
Novartis Investigative Site
Busan, South Korea, 49241
Actively Recruiting
3
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
4
Novartis Investigative Site
Taegu, South Korea, 41944
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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