Post-marketing Surveillance Protocol Number; CKJX839A11401

Specified drug-use survey of Leqvio Subcutaneous Injection [Familial hypercholesterolaemia or hypercholesterolaemia]

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230654

Enrollment

560

Registered

2024-02-27

Start date

2024-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial hypercholesterolaemia or hypercholesterolaemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who provided written informed consent to participate in this survey prior to the start of treatment with the product 2.Patients who received treatment with the product as per the package insert

Exclusion criteria

Exclusion criteria: 1.Patients who received treatment with a formulation containing the same ingredients as the product in the past. 2.Patients participating in other interventional studies at the time of informed consent 3.Patients planning to participate in other interventional studies during this survey

Design outcomes

Primary

Measure	Time frame
-Number and percentage of patients with adverse events -Numbers and percentages of patients with serious adverse events, adverse events by severity, and adverse drug reactions	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results