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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran | Patients who have been treated with inclisiran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Other | There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse events/adverse drug reactions (AEs/ADRs) | Cumulative incidences of AEs, ADRs, SAEs, Serious ADR(SADRs), Unexpected AEs, and Unexpected ADRs due to Leqvio® Pre-filled Syringe(inclisiran sodium) during the observation period ["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)] | up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles | Effectiveness of Leqvio® Pre-filled Syringe (inclisiran sodium) through changes in LDL-C and lipid profiles (total cholesterol, Apolipoprotein B (ApoB), non high-density lipoprotein cholesterol (non-HDL-C), Apolipoprotein A-1 (ApoA1), High Density Lipoprotein Cholesterol (HDL-C), Lipoprotein(a) (Lp(a)) and triglyceride). |
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Inclusion Criteria:
If a subject meets all of the following criteria, he/she can participate in this study:
Exclusion Criteria:
A subjects who meets any of the following criteria cannot participate in this study:
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This study will involve patients who received at least one dose of Leqvio for the treatment of primary hypercholesterolemia or mixed dyslipidemia according to the current label information in Korea.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Yangsan | Gyeongsangnam-do | 50612 | South Korea | |
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| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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| Baseline, Months 3, 9 and 15 |
| Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs | Impact of subjects' baseline characteristics(age, gender, pregnancy, BMI, lipid profile, cardiovascular risk factors and comorbidities) and medication & non-medication(reason for using the drug, usage period, amount of use, concomitant medications) on cumulative incidence of AEs and SAEs during the observation period. | up to 15months |
| Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles | Impact of subjects' baseline characteristics(age, gender, pregnancy, BMI, lipid profile, cardiovascular risk factors and comorbidities) and medication & non-medication(reason for using the drug, usage period, amount of use, concomitant medications) on the changes in LDL-C and lipid profiles after treatment compared to baseline. | up to 15 months |
| Novartis Investigative Site |
| Recruiting |
| Busan |
| 49241 |
| South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Recruiting | Taegu | 41944 | South Korea |