Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Novartis Pharmaceuticals1,500 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Primary Hypercholesterolemia or Mixed Dyslipidemia

Interventions

InclisiranOTHER

There is no treatment allocation. Patients administered Leqvio by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (4)

Novartis Investigative Site

Yangsan, Gyeongsangnam-do, South Korea

RECRUITING

Novartis Investigative Site

Busan, South Korea

RECRUITING

Novartis Investigative Site

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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 \["The term "unexpected" means that it is not listed in the domestic labeling(according to health authority regulations)\]

Time frame: up to 15 months

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: up to 15 months

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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