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Chart Review of Repatha® in Subjects With Hyperlipidaemia

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ClinicalTrials.gov Identifier: NCT02770131
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease
Hypercholesterolaemia

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Observational Serial Chart Review of Repatha® Use in European Subjects With Hyperlipidaemia
Actual Study Start Date : May 4, 2016
Estimated Primary Completion Date : June 24, 2021
Estimated Study Completion Date : June 24, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).



Primary Outcome Measures :
  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 Outcome Measures :
  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 52 weeks 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 52 weeks 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 52 weeks 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 52 weeks 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 52 weeks 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 52 weeks 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 52 weeks post first dose ]
    Record Repatha® administration device details, personal injector, autoinjector or pre-filled syringe throughout the observation period



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population comprises patients from European countries, who have received Repatha® as part of routine clinical management of their hyperlipidaemia, between August 2015 and June 2021.
Criteria

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®


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770131


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02770131     History of Changes
Other Study ID Numbers: 20130296
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Keywords provided by Amgen:
hypercholesterolaemia
lipid-lowering therapies

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases