Post-marketing Surveillance Protocol Number; CKJX839A11401

JRCT ID: jRCT2031230654

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Familial hypercholesterolaemia or hypercholesterolaemia
• Date of first enrollment: 01/03/2024
• Target sample size: 560
• Study type: Observational

Outcome(s)

Primary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 15age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: sato masayuki