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

Study identification

• 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

Study timelines

Date when funding contract was signed

Planned:21/04/2016

Actual:17/07/2015

Study start date

Planned:06/06/2016

Actual:24/06/2016

Data analysis start date

Planned:23/01/2023

Actual:04/08/2023

Date of final study report

Planned:30/06/2023

Actual:11/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only