Active — Not RecruitingNot Applicable

Specified Drug-use Survey of Leqvio for s.c. Injection.

Japan585 participantsStarted 2024-03-04

Plain-language summary

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Who can participate

Age range15 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who provided written informed consent to participate in this survey prior to the start of treatment with Leqvio. * Patients who received treatment with Leqvio as per the package insert. Exclusion Criteria: * Patients who received treatment with a formulation containing the same ingredients as Leqvio in the past. * Patients participating in other interventional studies at the time of informed consent. * Patients planning to participate in other interventional studies during this survey.

What they're measuring

Number of patients with adverse events

Timeframe: Up to 24 months

Numbers of patients with serious adverse events, adverse events by severity, and adverse drug reactions

Timeframe: Up to 24 months

Trial details

NCT IDNCT06275724

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-17

View on ClinicalTrials.gov More Familial Hypercholesterolaemia trials