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Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)

NCT ID: NCT06770543

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-13

Study Completion Date

2031-01-02

Brief Summary

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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).

Detailed Description

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Conditions

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Primary Hypercholesterolemia or Mixed Dyslipidemia

Keywords

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primary hypercholesterolemia, mixed dyslipidemia inclisiran Leqvio

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inclisiran

Patients who have been treated with inclisiran

Inclisiran

Intervention Type 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.

Interventions

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Inclisiran

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

Intervention Type OTHER

Other Intervention Names

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Leqvio®

Eligibility Criteria

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Inclusion Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Novartis Investigative Site

Busan, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Taegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CKJX839A1KR01

Identifier Type: -

Identifier Source: org_study_id