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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab (AMG 145) in Japan

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 Summary: 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
Sponsor: Amgen

Current Primary Outcome:

  • Incidence of adverse events and adverse drug reactions [ Time Frame: 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 [ Time Frame: 2 years ]
  • Laboratory values for HDL-C [ Time Frame: 2 years ]
  • Laboratory values for total cholesterol [ Time Frame: 2 years ]
  • Laboratory values for triglycerides [ Time Frame: 2 years ]
  • Laboratory values for Apolipoprotein (Apo) A1 [ Time Frame: 2 years ]
    This will be measured if feasible.
  • Laboratory values for Apolipoprotein (Apo) Apo B [ Time Frame: 2 years ]
    This will be measured if feasible.
  • Laboratory values for Apolipoprotein (Apo) Apo E [ Time Frame: 2 years ]
    This will be measured if feasible.
  • Laboratory values for lipoprotein(a) [ Time Frame: 2 years ]
    This will be measured if feasible.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Amgen

Dates:
Date Received: June 7, 2016
Date Started: June 2016
Date Completion: April 2022
Last Updated: January 13, 2017
Last Verified: January 2017