Chart Review of Repatha® in Subjects With Hyperlipidaemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02770131|
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : August 3, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|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|
To describe the clinical characteristics of subjects at initiation of Repatha® (up to 2000 subjects).
- 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
- 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).
- 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
- 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
- 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.
- 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
- 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)
- 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
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
|Contact: Amgen Call Centerfirstname.lastname@example.org|
Show 155 Study Locations