Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan

Amgen

Status: Completed

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02808403

20140409

Details and patient eligibility

About

The purpose of this post-marketing survey is to obtain real-world information on the safety and effectiveness of evolocumab in Japan.

Full description

The objectives of study are to 1) determine the incidence of adverse events and adverse drug reactions among patients receiving evolocumab for up to 2 years, and 2) identify and describe patient characteristics (e.g. demographics, medical history) associated with the safety and effectiveness of evolocumab therapy for the patients with Familial Hypercholesterolemia (Heterozygous or Homozygous) and Hypercholesterolemia in Japan

Enrollment: 6,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information (i.e., those with Familial Hypercholesterolemia (Heterozygous or Homozygous and Hypercholesterolemia who have high risk factors for cardiovascular event and do not respond sufficiently to HMGCoA reductase inhibitor (statin) for hypercholesterolemia).

Exclusion criteria

• No exclusion criteria are applied.

Trial design

6,000 participants in 1 patient group

Evolocumab exposed

Description:

Patients for whom evolocumab is prescribed. Dosage, period (start/end date), frequency of injection (Every 2 weeks (Q2W), Every 4 weeks (Q4W)), drug withdrawal (Yes or No, date, reason) and injection site (upper arm, abdomen, thigh) of evolocumab will be collected.

Treatment:

Other: No intervention