NCT06770543Recruiting
Leqvio rPMS (Regulatory Post-Marketing Surveillance in Korea)
Regulatory Post-Marketing Surveillance (rPMS) Study for Leqvio® Pre-filled Syringe(Inclisiran Sodium)
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- 13 Aug 2025
- Primary completion date
- 2 Jan 2031
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06770543
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 13 Aug 2025 to the primary completion date, 2 Jan 2031
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participating in clinical trials of other investigational drugs
Other
- A subjects who meets any of the following criteria cannot participate in this study:
- Contraindications in accordance with domestic prescribing information
- Patients who do not provide consent to participate in the study
Who the study is looking for
- 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)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Taegu | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Yangsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.