Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Not yet recruiting

• Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia

• Registration Number: NCT06770543
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-03-29
• Primary Completion: 2031-01-02
• Study Completion: 2031-01-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

If a subject meets all of the following criteria, he/she can participate in this study:

1. 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
2. Patients who are unable to reach LDL-C target with maximum tolerated dose of statin, or patients with statin intolerance
3. 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:

1. Contraindications in accordance with domestic prescribing information
2. Patients participating in clinical trials of other investigational drugs
3. Patients who do not provide consent to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidences of adverse events/adverse drug reactions (AEs/ADRs)	up to 15 months	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 \["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)\]

Secondary Outcome Measures

Name	Time	Method
Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles	Baseline, Months 3, 9 and 15	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).
Impact of subjects' baseline characteristics and medication usage on cumulative incidence of AEs and SAEs	up to 15months	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.
Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles	up to 15 months	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.