Chart Review of Repatha® in Subjects With Hyperlipidaemia

N/ACompletedNCT02770131

Amgen1,986 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,986

Conditions

Hypercholesterolaemia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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®

Locations (183)

Outcomes

Primary Outcomes

Description of clinical characteristics of subjects initiated on Repatha®

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

Time frame: Study day 1

Secondary Outcomes

Describe LDL-C and other cholesterol values over time

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

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

Describe Repatha® dose over time

Record Repatha® dose in mg

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

Describe use of other lipid-modifying therapies

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

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

Describe Physician visits

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

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

Describe hospitalizations

Detail all hospitalizations from enrolment to end of study

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

Describe Repatha® dose frequency over time

Record dose frequency (Q2W, QM)

Data from ClinicalTrials.gov

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Research Site

Feldkirch, Austria

Research Site

Graz, Austria

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Innsbruck, Austria

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Klagenfurt, Austria

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Linz, Austria

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Salzburg, Austria

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Vienna, Austria

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Vienna, Austria

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Vienna, Austria

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Vienna, Austria

...and 173 more locations