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

Completed

• Conditions: Hypercholesterolemia; Familial Hypercholesterolemia
• Interventions: Other: No intervention

• Registration Number: NCT02808403
• Lead Sponsor: Amgen

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-21
• Study Start: 2016-06-24
• Primary Completion: 2022-10-31
• Study Completion: 2023-03-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Evolocumab exposed	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Laboratory values for HDL-C	2 years
Incidence of adverse events and adverse drug reactions	2 years	The incidence of adverse events and drug reactions will be described using the same units (events per 1000 person-years). Adverse events (including seriousness and causal relations to drug or device), inclusive of reaction at local injection sites, and other safety information (e.g. overdose, lack of effectiveness, pregnancy and lactation with or without adverse event) will be described.
Laboratory values for LDL-C	2 years
Laboratory values for total cholesterol	2 years
Laboratory values for triglycerides	2 years
Laboratory values for lipoprotein(a)	2 years	This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) A1	2 years	This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo B	2 years	This will be measured if feasible.
Laboratory values for Apolipoprotein (Apo) Apo E	2 years	This will be measured if feasible.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Kofu city, Yamanashi Prefecture, Japan