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OpenTrials
Completed

NCT Number: NCT02770131

Chart Review of Repatha® in Subjects With Hyperlipidaemia

Review of clinical characteristics of patients who are prescribed Repatha® and how their treatment is managed.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults (>18 years) Provided informed consent Initiated on Repatha® at physician's discretion, after 1st August 2015 Received at least one dose of Repatha®

Exclusion criteria

Enrolled in an interventional study of PCSK9 inhibitor within 12 weeks prior to initiation of Repatha® Received commercially available PCSK9 inhibitor within 12 weeks prior to initiation of Repatha®

Treatment and study plan

Primary outcomes

  1. Description of clinical characteristics of subjects initiated on Repatha®

    Time frame: Study day 1

    Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance

Secondary outcomes

  1. Describe LDL-C and other cholesterol values over time

    Time frame: Up to 26 weeks prior to the first dose of Repatha®, up to 30 months post first dose of Repatha®

    Detail all cholesterol assessments recorded during the observation period (Total Cholesterol, LDL-C, HDL-C, Non-HDL-C and Triglycerides).

  2. Describe Repatha® dose over time

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Record Repatha® dose in mg

  3. Describe use of other lipid-modifying therapies

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Describe lipid-modifying therapies over time, type, dose and dose frequency during the observation period

  4. Describe Physician visits

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Collection of all primary and secondary healthcare visit dates and classification as to cardiovascular and non-cardiovascular.

  5. Describe hospitalizations

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Detail all hospitalizations from enrolment to end of study

  6. Describe Repatha® dose frequency over time

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Record dose frequency (Q2W, QM)

  7. Describe Repatha® administrative device use over time

    Time frame: From the first dose of Repatha® up to 30 months post first dose

    Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia

Acronym: HEYMANS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 12, 2016
Registry last updated
Jun 6, 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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