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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01375764
Registration number
NCT01375764
Ethics application status
Date submitted
16/06/2011
Date registered
17/06/2011
Date last updated
7/11/2022
Titles & IDs
Public title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
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Scientific title
A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
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Secondary ID [1]
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20090159
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Universal Trial Number (UTN)
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Trial acronym
GAUSS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Evolocumab
Treatment: Drugs - Ezetimibe
Other interventions - Placebo to Evolocumab
Active Comparator: Ezetimibe - Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Experimental: Evolocumab + Ezetimibe - Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Experimental: Evolocumab 280 mg - Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Experimental: Evolocumab 350 mg - Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Experimental: Evolocumab 420 mg - Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Other interventions: Evolocumab
Administered by subcutaneous injection
Treatment: Drugs: Ezetimibe
Administered orally once a day
Other interventions: Placebo to Evolocumab
Administered by subcutaneous injection
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
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Assessment method [1]
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LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [1]
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Baseline and Week 12
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Primary outcome [2]
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Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [2]
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LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [1]
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Change From Baseline in LDL-C at Week 12
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Assessment method [1]
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LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [2]
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LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Percent Change From Baseline in Non-HDL-C at Week 12
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Assessment method [3]
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LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [4]
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LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Percent Change From Baseline in Apolipoprotein B at Week 12
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Assessment method [5]
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LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [6]
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LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
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Assessment method [7]
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LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [7]
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Baseline and Week 12
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Secondary outcome [8]
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Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [8]
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LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
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Assessment method [9]
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LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
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Timepoint [9]
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Baseline and Week 12
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Secondary outcome [10]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
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Assessment method [10]
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LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
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Timepoint [10]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
- Male or female = 18 to = 75 years of age
- On a statin or a low dose statin with stable dose for at least 4 weeks
- Lipid lowering therapy has been stable prior to enrollment
- Fasting triglycerides must be < 400 mg/dL.
- Subject not at LDL-C goal
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- New York Heart Association (NYHA) III or IV heart failure or known left ventricular
ejection fraction < 30%
- Uncontrolled cardiac arrhythmia
- Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
- Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
- Uncontrolled hypertension
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/05/2012
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Sydney
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Recruitment hospital [3]
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Research Site - Melbourne
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Recruitment hospital [4]
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Research Site - Perth
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Recruitment postcode(s) [1]
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2015 - Camperdown
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Recruitment postcode(s) [2]
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2022 - Sydney
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Georgia
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Montana
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United States of America
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Nevada
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Tennessee
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Belgium
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Bruxelles
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Belgium
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Uccle
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Newfoundland and Labrador
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Canada
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Quebec
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Denmark
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Ballerup
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Denmark
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Vejle
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Finland
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Helsinki
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Finland
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OYS
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Spain
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Aragón
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Spain
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Aragón
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Spain
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Cataluña
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Spain
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Cataluña
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Göteborg
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Göteborg
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Lund
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Sweden
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein
cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective
dose of a statin.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01375764
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Trial related presentations / publications
Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01375764
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