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.

• Register: EUCTR
• Last refreshed on: 16 January 2017
• Main ID: EUCTR2014-001976-75-SE
• Date of registration: 30/07/2014
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: 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.
• Scientific title: 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: 11/09/2014
• Target sample size: 4000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001976-75
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: Evolocumab
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Evolocumab
Current Sponsor code: Evolocumab
Other descriptive name: AMG145
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 140-
Pharmaceutical form of the placebo: Solution for injection in pre-filled pen
Route of administration of the placebo: Subcutaneous use

Product Name: Evolocumab
Product Code: AMG 145
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: evolocumab
Current Sponsor code: AMG 145
Other descriptive name: AMG145
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Pharmaceutical form of the placebo: Solution for injection in cartridge
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

Primary end point(s): The primary endpoint is the SWM strategy index of executive function.

Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment

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.

Secondary Outcome(s)

Secondary end point(s): Secondary endpoints are:
• SWM between-errors score
• PAL total errors adjusted
• RTI median 5-choice reaction time.

Timepoint(s) of evaluation of this end point: From baseline assessment to end of study visit assessment

Secondary ID(s)

20130385

Source(s) of Monetary Support

Amgen Inc.