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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Taegu
Novartis Investigative Site
RECRUITING
Yangsan
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-08-13
Estimated Completion Date: 2031-01-02
Participants
Target number of participants: 1500
Treatments
Inclisiran
Patients who have been treated with inclisiran
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov