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Completed

NCT Number: NCT02808403

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

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

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ichinomiya, Aichi-ken, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention; observation of routine medical care

Primary outcomes

  1. 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.

  2. Laboratory values for LDL-C

    Time frame: 2 years

  3. Laboratory values for HDL-C

    Time frame: 2 years

  4. Laboratory values for total cholesterol

    Time frame: 2 years

  5. Laboratory values for triglycerides

    Time frame: 2 years

  6. Laboratory values for Apolipoprotein (Apo) A1

    Time frame: 2 years

    This will be measured if feasible.

  7. Laboratory values for Apolipoprotein (Apo) Apo B

    Time frame: 2 years

    This will be measured if feasible.

  8. Laboratory values for Apolipoprotein (Apo) Apo E

    Time frame: 2 years

    This will be measured if feasible.

  9. Laboratory values for lipoprotein(a)

    Time frame: 2 years

    This will be measured if feasible.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Jun 21, 2016
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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