Study Description
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 Uncontrolled, central registration system, multicenter, special drug use-results
surveillance.
This is a prospective, open-label, multicenter, single-arm observational study
(non-interventional study: NIS) conducted only in Japan.
The survey will include patients with familial hypercholesterolaemia or
hypercholesterolaemia who have received treatment with Leqvio. Patients who discontinued
treatment with Leqvio before completing the 24-month observation period will be followed
for safety until the date of the last dose of Leqvio plus 180 days or until 24 months
after the first dose of Leqvio, whichever comes earlier.
Interventions
inclisiran
Eligibility Criteria
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.
Worldwide Contacts
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