Chart Review of Repatha® in Subjects With Hyperlipidaemia

Completed

• Conditions: Hypercholesterolaemia

• Registration Number: NCT02770131
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study Start: 2016-05-04
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1986

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®

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of clinical characteristics of subjects initiated on Repatha®	Study day 1	Age at initiation of Repatha®, Gender Familial hypercholesterolaemia status Diabetic status, Cardiovascular history History of statin intolerance

Secondary Outcome Measures

Name	Time	Method
Describe Repatha® dose over time	From the first dose of Repatha® up to 30 months post first dose	Record Repatha® dose in mg
Describe hospitalizations	From the first dose of Repatha® up to 30 months post first dose	Detail all hospitalizations from enrolment to end of study
Describe Repatha® administrative device use over time	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
Describe LDL-C and other cholesterol values over time	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).
Describe use of other lipid-modifying therapies	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
Describe Physician visits	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.
Describe Repatha® dose frequency over time	From the first dose of Repatha® up to 30 months post first dose	Record dose frequency (Q2W, QM)

Trial Locations

Locations (1)

Research Site; 🇨🇭 Zurich, Switzerland