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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01763905
Registration number
NCT01763905
Ethics application status
Date submitted
7/01/2013
Date registered
9/01/2013
Date last updated
20/07/2020
Titles & IDs
Public title
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
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Scientific title
A Double-blind, Randomized, Multicenter Study to Evaluate Safety and Efficacy of AMG 145, 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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2012-001364-30
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Secondary ID [2]
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20110116
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Universal Trial Number (UTN)
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Trial acronym
GAUSS-2
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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: Other - Evolocumab
Treatment: Drugs - Placebo to Evolocumab
Treatment: Drugs - Ezetimibe
Treatment: Drugs - Placebo to Ezetimibe
Active comparator: Ezetimibe (Q2W) - Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Active comparator: Ezetimibe (QM) - Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Experimental: Evolocumab Q2W - Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Experimental: Evolocumab QM - Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Treatment: Other: Evolocumab
Subcutaneous injection
Treatment: Drugs: Placebo to Evolocumab
Subcutaneous injection
Treatment: Drugs: Ezetimibe
Tablet for oral administration
Treatment: Drugs: Placebo to Ezetimibe
Tablet for oral administration
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Intervention code [1]
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Treatment: Other
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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 LDL-C at Week 12
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Assessment method [1]
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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 the Mean of Weeks 10 and 12
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Assessment method [2]
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Timepoint [2]
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Baseline and Weeks 10 and 12
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Secondary outcome [1]
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Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
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Assessment method [1]
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Timepoint [1]
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Baseline and Weeks 10 and 12
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Secondary outcome [2]
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Change From Baseline in LDL-C at Week 12
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Assessment method [2]
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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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Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)
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Assessment method [3]
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Timepoint [3]
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Weeks 10 and 12
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Secondary outcome [4]
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Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12
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Assessment method [4]
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
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Assessment method [5]
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Timepoint [5]
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Baseline and Weeks 10 and 12
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Secondary outcome [6]
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Percent Change From Baseline in Non-HDL-C at Week 12
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Assessment method [6]
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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 Apolipoprotein B at the Mean of Weeks 10 and 12
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Assessment method [7]
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Timepoint [7]
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Baseline and Weeks 10 and 12
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Secondary outcome [8]
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Percent Change From Baseline in Apolipoprotein B at Week 12
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Assessment method [8]
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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 the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12
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Assessment method [9]
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Timepoint [9]
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Baseline and Weeks 10 and 12
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Secondary outcome [10]
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Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12
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Assessment method [10]
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
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Assessment method [11]
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Timepoint [11]
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Baseline and Weeks 10 and 12
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Secondary outcome [12]
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Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
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Assessment method [12]
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Timepoint [12]
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Baseline and Week 12
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Secondary outcome [13]
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Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12
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Assessment method [13]
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Timepoint [13]
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Baseline and Weeks 10 and 12
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Secondary outcome [14]
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Percent Change From Baseline in Lipoprotein (a) at Week 12
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Assessment method [14]
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Timepoint [14]
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Baseline and Week 12
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Secondary outcome [15]
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Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
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Assessment method [15]
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Timepoint [15]
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Baseline and Weeks 10 and 12
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Secondary outcome [16]
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Percent Change From Baseline in Triglycerides at Week 12
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Assessment method [16]
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Timepoint [16]
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Baseline and Week 12
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Secondary outcome [17]
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Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12
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Assessment method [17]
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Timepoint [17]
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Baseline and Weeks 10 and 12
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Secondary outcome [18]
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Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12
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Assessment method [18]
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Timepoint [18]
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Baseline and Week 12
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Secondary outcome [19]
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Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12
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Assessment method [19]
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Timepoint [19]
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Baseline and Weeks 10 and 12
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Secondary outcome [20]
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Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12
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Assessment method [20]
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Timepoint [20]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
* Male or female = 18 to = 80 years of age
* Not on a statin or on a low dose statin with stable dose for at least 4 weeks
* History of intolerance to at least 2 statins
* Subject not at LDL-C goal
* 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
Years
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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
24/01/2013
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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
19/11/2013
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Sample size
Target
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Accrual to date
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Final
307
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,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 - Milton
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Research Site - Melbourne
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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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4064 - Milton
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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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Michigan
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United States of America
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Missouri
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Nevada
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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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Oklahoma
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United States of America
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Texas
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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La Louvière
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Ontario
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Aalborg
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Ballerup
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France
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France
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Vénissieux
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Bad Krozingen
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Germany
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Germany
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Heppenheim
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Alkmaar
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Lodz
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Warszawa
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Gauteng
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Western Cape
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Lugano
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Reinach
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Liverpool
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London
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United Kingdom
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Telford
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West Bromwich
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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 (SC) evolocumab every 2 weeks (Q2W) and monthly (QM), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an effective dose of a statin (HMG-CoA (5-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors).
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Trial website
https://clinicaltrials.gov/study/NCT01763905
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Trial related presentations / publications
Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1. Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7. 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. Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16. Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, Xue A, Scott R, Wasserman SM, Stroes E. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014 Mar;37(3):131-9. doi: 10.1002/clc.22248. Epub 2014 Jan 29. Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Dent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco M; GAUSS-2 Investigators. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2541-2548. doi: 10.1016/j.jacc.2014.03.019. Epub 2014 Mar 30. Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932. Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21. Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2. Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.
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Public notes
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Contacts
Principal investigator
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MD
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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/NCT01763905
Download to PDF