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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EUCTR |
Last refreshed on:
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12 December 2016 |
Main ID: |
EUCTR2014-001976-75-GR |
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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Study to Assess the Effect of Evolocumab on Ability to Learn Compared with Placebo in patients with Cardiovascular Disease who are already taking Statin Therapy.
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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
Evolocumab (AMG 145) - EBBINGHAUS |
Date of first enrolment:
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22/09/2014 |
Target sample size:
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4000 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001976-75 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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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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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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Singapore
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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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Taiwan
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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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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Signed informed consent for Study 20130385
2) Randomized into Study 20110118 (FOURIER) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1600
Exclusion criteria: 1) Current or known past diagnosis of dementia or mild cognitive impairment (MCI)
2) Any condition or situation, including other significant mental or neurological disorders that, in the investigator’s opinion, may confound the study results, or may interfere significantly with the subject’s participation in Study 20130385 or in Study 20110118
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Dyslipidemia MedDRA version: 17.0
Level: LLT
Classification code 10020604
Term: Hypercholesterolemia
System Organ Class: 100000004861
MedDRA version: 17.0
Level: LLT
Classification code 10058110
Term: Dyslipidemia
System Organ Class: 100000004861
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Intervention(s)
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Product Name: Evolocumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in pre-filled pen Pharmaceutical form of the placebo: Solution for infusion in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Product Name: Evolocumab Product Code: AMG 145 Pharmaceutical Form: Solution for injection in cartridge Pharmaceutical form of the placebo: Solution for injection in cartridge Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To evaluate change over time in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo in the following: • Working memory, as assessed by the CANTAB Spatial Working Memory (SWM) test between-errors score • Memory function, as assessed by the CANTAB Paired Associates Learning (PAL) test • Psychomotor speed, as assessed by the CANTAB Reaction Time (RTI) test.
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Main Objective: To evaluate change over time in executive function, as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory (SWM) strategy index of executive function, in subjects receiving statin therapy in combination with evolocumab, compared with subjects receiving statin therapy in combination with placebo.
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Primary end point(s): The primary endpoint is the SWM strategy index of executive function.
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Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment
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Secondary end point(s): Secondary endpoints are:
• SWM between-errors score
• PAL total errors adjusted
• RTI median 5-choice reaction time.
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Secondary ID(s)
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2014-001976-75-SE
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20130385
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Source(s) of Monetary Support
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Amgen Inc.
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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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