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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01984424
Registration number
NCT01984424
Ethics application status
Date submitted
8/11/2013
Date registered
14/11/2013
Date last updated
29/11/2018
Titles & IDs
Public title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3
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Scientific title
A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
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Secondary ID [1]
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2013-000935-29
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Secondary ID [2]
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20120332
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Universal Trial Number (UTN)
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Trial acronym
GAUSS-3
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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
Treatment: Drugs - Atorvastatin
Treatment: Drugs - Placebo to Atorvastatin
Other interventions - Placebo to Ezetimibe
Treatment: Drugs - Ezetimibe
Other interventions - Placebo to Evolocumab
Treatment: Drugs - Evolocumab
Other: Part A: Atorvastatin 20 mg => Placebo - Participants received atorvastatin 20 mg orally for 10 weeks (period 1) followed by placebo orally for 10 weeks (period 2), separated by a 2-week washout period.
Other: Part A: Placebo => Atorvastatin 20 mg - Participants received placebo orally for 10 weeks (period 1) followed by atorvastatin 20 mg orally for 10 weeks (period 2), separated by a 2-week washout period.
Active comparator: Part B: Ezetimibe - Participants received 10 mg ezetimibe orally only a day and placebo to evolocumab by subcutaneous injection once a month for 24 weeks.
Experimental: Part B: Evolocumab - Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo to ezetimibe orally once a day for 24 weeks.
Experimental: Part C: Open-label Evolocumab - Participants who completed part B and were eligible to proceed to open-label extension part C and could choose quarterly between evolocumab 420 mg once a month or evolocumab 140 mg every 2 weeks for up to 2 years.
Treatment: Drugs: Atorvastatin
Atorvastatin was supplied as over-encapsulated 20 mg tablets
Treatment: Drugs: Placebo to Atorvastatin
Placebo matching to atorvastatin supplied as over-encapsulated tablets
Other interventions: Placebo to Ezetimibe
Placebo matching to Ezetimibe supplied as over-encapsulated tablets.
Treatment: Drugs: Ezetimibe
Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.
Other interventions: Placebo to Evolocumab
Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)
Treatment: Drugs: Evolocumab
Evolocumab supplied as single-use prefilled autoinjector/pen(s)
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 LDL-C at the Mean of Weeks 22 and 24
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Assessment method [1]
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Timepoint [1]
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Baseline and weeks 22 and 24
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Primary outcome [2]
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Percent Change From Baseline in LDL-C at Week 24
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Assessment method [2]
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Timepoint [2]
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Baseline and week 24
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Secondary outcome [1]
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Change From Baseline in LDL-C at the Mean of Weeks 22 and 24
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Assessment method [1]
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Timepoint [1]
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Baselie and weeks 22 and 24
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Secondary outcome [2]
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Change From Baseline in LDL-C at Week 24
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Assessment method [2]
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Timepoint [2]
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Baseline and week 24
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Secondary outcome [3]
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Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL
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Assessment method [3]
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Timepoint [3]
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Weeks 22 and 24
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Secondary outcome [4]
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Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL
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Assessment method [4]
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24
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Assessment method [5]
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Timepoint [5]
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Baseline and weeks 22 and 24
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Secondary outcome [6]
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Percent Change From Baseline in Total Cholesterol at Week 24
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Assessment method [6]
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Timepoint [6]
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Baseline and week 24
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Secondary outcome [7]
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Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24
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Assessment method [7]
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Timepoint [7]
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Baseline and weeks 22 and 24
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Secondary outcome [8]
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Percent Change From Baseline in Non-HDL-C at Week 24
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Assessment method [8]
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Timepoint [8]
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Baseline and week 24
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Secondary outcome [9]
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Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24
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Assessment method [9]
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Timepoint [9]
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Baseline and weeks 22 and 24
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Secondary outcome [10]
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Percent Change From Baseline in Apolipoprotein B at Week 24
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Assessment method [10]
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Timepoint [10]
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Baseline and week 24
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Secondary outcome [11]
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Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24
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Assessment method [11]
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Timepoint [11]
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Baseline and weeks 22 and 24
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Secondary outcome [12]
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Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24
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Assessment method [12]
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Timepoint [12]
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Baseline and week 24
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Secondary outcome [13]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24
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Assessment method [13]
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Timepoint [13]
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Baseline and Weeks 22 and 24
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Secondary outcome [14]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24
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Assessment method [14]
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Timepoint [14]
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Baseline and week 24
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Secondary outcome [15]
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Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24
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Assessment method [15]
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Timepoint [15]
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Baseline and Weeks 22 and 24
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Secondary outcome [16]
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Percent Change From Baseline in Lipoprotein(a) at Week 24
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Assessment method [16]
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Timepoint [16]
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Baseline and week 24
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Secondary outcome [17]
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Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24
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Assessment method [17]
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Timepoint [17]
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Baseline and weeks 22 and 24
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Secondary outcome [18]
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Percent Change From Baseline in Triglycerides at Week 24
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Assessment method [18]
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Timepoint [18]
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Baseline and week 24
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Secondary outcome [19]
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Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24
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Assessment method [19]
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Timepoint [19]
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Baseline and weeks 22 and 24
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Secondary outcome [20]
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Percent Change From Baseline in HDL-C at Week 24
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Assessment method [20]
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Timepoint [20]
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Baseline and week 24
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Secondary outcome [21]
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Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24
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Assessment method [21]
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Timepoint [21]
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Baseline and weeks 22 and 24
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Secondary outcome [22]
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Percent Change From Baseline in VLDL-C at Week 24
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Assessment method [22]
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Timepoint [22]
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Baseline and week 24
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Eligibility
Key inclusion criteria
* Male or female = 18 to = 80 years of age
* Subject not at LDL-C goal
* History of statin intolerance
* Lipid lowering therapy has been stable prior to enrolment for at least 4 weeks
* Fasting triglycerides = 400 mg/dL
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Minimum age
18
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Maximum age
80
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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
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes
* Poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism
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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 3
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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
10/12/2013
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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
21/11/2017
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Sample size
Target
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Accrual to date
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Final
511
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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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 - Woolloongabba
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Recruitment hospital [3]
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Research Site - Ashford
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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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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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5035 - Ashford
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Recruitment outside Australia
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United States of America
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California
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Georgia
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Illinois
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Kansas
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Maryland
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Nantes Cedex 1
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France
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Paris Cedex 13
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France
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Vénissieux
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Oslo
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Ålesund
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Gauteng
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Western Cape
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Birmingham
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Newcastle upon Tyne
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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 of this study was to evaluate the effect of 24 weeks of evolocumab administered subcutaneously (SC) every month, compared with ezetimibe, on low-density lipoprotein cholesterol (LDL-C) levels in adults with high cholesterol who are unable to tolerate an effective dose of a statin due to muscle-related side effects (MRSE).
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Trial website
https://clinicaltrials.gov/study/NCT01984424
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Trial related presentations / publications
Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7. Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3. Nissen SE, Stroes E, Dent-Acosta RE, Rosenson RS, Lehman SJ, Sattar N, Preiss D, Bruckert E, Ceska R, Lepor N, Ballantyne CM, Gouni-Berthold I, Elliott M, Brennan DM, Wasserman SM, Somaratne R, Scott R, Stein EA; GAUSS-3 Investigators. Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1580-90. doi: 10.1001/jama.2016.3608.
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Public notes
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Contacts
Principal investigator
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MD
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Address
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Amgen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01984424
Download to PDF