Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Recruiting · NCT06770543 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
Inclisiran
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).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
4 locations listed.
- Novartis Investigative Site - Busan, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Taegu, South Korea
- Novartis Investigative Site - Yangsan, Gyeongsangnam-do, South Korea