Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02207634 |
Date of registration:
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31/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects
EBBINGHAUS |
Scientific title:
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A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial |
Date of first enrolment:
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September 10, 2014 |
Target sample size:
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1974 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02207634 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Canada
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Czech Republic
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Czechia
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hong Kong
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Hungary
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Italy
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Japan
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Latvia
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Lithuania
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Malaysia
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Russian Federation
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Slovakia
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South Africa
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Spain
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Sweden
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Turkey
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United Kingdom
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United States
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Contacts
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Name:
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MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Amgen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Randomized into Study 20110118 (FOURIER; NCT01764633)
Exclusion Criteria:
- Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
Age minimum:
40 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dyslipidemia
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Intervention(s)
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Biological: Evolocumab
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Drug: Background Statin Therapy
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Drug: Placebo
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Primary Outcome(s)
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Mean Change from baseline over time in Spatial Working Memory (SWM) index of executive function
[Time Frame: Mean of data collected over the study duration (up to 4 years)]
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Secondary Outcome(s)
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Mean Change from baseline over time in Reaction Time (RTI) median 5-choice reaction time
[Time Frame: Mean of data collected over the study duration (up to 4 years)]
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Mean Change from baseline over time in Paired Associated Learning (PAL) total errors adjusted.
[Time Frame: Mean of data collected over the study duration (up to 4 years)]
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Mean Change from baseline over time in Spatial Working Memory (SWM) between-errors score
[Time Frame: Mean of data collected over the study duration (up to 4 years)]
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Secondary ID(s)
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20130385
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2014-001976-75
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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