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Clinical Trial 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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06275724
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +81337978748
Email novartis.email@novartis.com
Status Recruiting
Phase
Start date March 4, 2024
Completion date December 31, 2027

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