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NCT Number: NCT06770543

Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

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).

Recruiting

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Key information

Conditions

Primary Hypercholesterolemia or Mixed Dyslipidemia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Yangsan, Gyeongsangnam-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Leqvio®

Primary outcomes

  1. Incidences of adverse events/adverse drug reactions (AEs/ADRs)

    Time frame: 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 outcomes

  1. Change from baseline in low-density lipoprotein-cholesterol (LDL-C) and lipid profiles

    Time frame: 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).

  2. 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(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.

  3. Impact of subjects' baseline characteristics and medication usage on changes from baseline in LDL-C and lipid profiles

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jan 13, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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