Study identification

PURI

https://redirect.ema.europa.eu/resource/17126

EU PAS number

EUPAS13676

Study ID

17126

Official title and acronym

Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan (20140409) (Evolocumab Long term PMS Japan)

DARWIN EU® study

No

Study countries

Japan

Study description

To assess the safety and effectiveness in the patients with familial hypercholesterolemia (heterozygous or homozygous) and hypercholesterolemia for long term (2years) treatment of evolocumab injection in a real world medical practice in Japan, with particular focus on the safety specifications as described in Japanese Risk Management Plan, hypersensitivity and immunogenicity as important potential risks, and use in the following patient sub-populations as important missing information: patients with homozygous familial hypercholesterolemia including pediatric, elderly patients ≥ 75 years old, patients with hepatic impairment, patients with hepatitis C, and long-term use including effects of persistent LDL-C level < 40 mg/dL (< 1.0 mmol/L).

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.
Study protocol
Initial protocol

Study_20140409_Evolocumab_Japan_PMS_Protocol_Amgen Format_ver2_20160513 - Clean

English (1.59 MB - PDF)View document
Updated protocol

Study_20140409_Evolocumab_Japan_PMS_Protocol_Amgen Format_ver2_20160525

English (1.66 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only