Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inclisiran.
- Who it may be relevant to
- Registry conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Overview
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).
Interventions
- 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.
Primary outcome measures
- Incidences of adverse events/adverse drug reactions (AEs/ADRs) [Time frame: up to 15 months]
Secondary outcome measures (3)
- Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles [Time frame: Baseline, Months 3, 9 and 15]
- Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs [Time frame: up to 15months]
- Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles [Time frame: up to 15 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 4 centers
- Novartis Investigative Site — Yangsan
- Novartis Investigative Site — Busan
- Novartis Investigative Site — Seoul
- Novartis Investigative Site — Taegu
Identifiers
NCT: NCT06770543 · CKJX839A1KR01