Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

Novartis

Status: Enrolling

Conditions: Primary Hypercholesterolemia or Mixed Dyslipidemia

Treatments: Other: Inclisiran

Study type: Observational

Funder types: Industry

Identifiers

NCT06770543

CKJX839A1KR01

Details and patient eligibility

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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Inclisiran

Description:

Patients who have been treated with inclisiran

Treatment:

Other: Inclisiran