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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/NCT02023879
Registration number
NCT02023879
Ethics application status
Date submitted
6/12/2013
Date registered
30/12/2013
Date last updated
27/07/2018
Titles & IDs
Public title
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Alirocumab in Patients With Primary Hypercholesterolemia Not Treated With a Statin
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Secondary ID [1]
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2013-002659-14
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Secondary ID [2]
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EFC13786
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
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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 - Alirocumab
Treatment: Drugs - Placebo (for Alirocumab)
Treatment: Drugs - Non-statin LMT
Other interventions - Diet Alone
Placebo Comparator: Placebo Q2W - Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed.
Other: Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator) - Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C =70 mg/dL (1.81 mmol/L) or =100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
Experimental: Alirocumab 150 mg Q4W/Up to 150 mg Q2W - Period 1: Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C =70 mg/dL (1.81 mmol/L) or =100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed.
Treatment: Drugs: Alirocumab
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Treatment: Drugs: Placebo (for Alirocumab)
Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
Treatment: Drugs: Non-statin LMT
Ezetimibe or Fenofibrate at stable dose as background therapy.
Other interventions: Diet Alone
Stable cholesterol-lowering diet as background therapy.
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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 Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)
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Assessment method [1]
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Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
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Timepoint [1]
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From Baseline to Week 24
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Secondary outcome [1]
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Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
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Assessment method [1]
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Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).
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Timepoint [1]
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From Baseline to Week 24
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Secondary outcome [2]
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Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
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Assessment method [2]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [2]
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From Baseline to Week 24
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Secondary outcome [3]
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Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
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Assessment method [3]
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
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Timepoint [3]
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From Baseline to Week 24
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Secondary outcome [4]
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Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis
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Assessment method [4]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
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Timepoint [4]
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From Baseline to Week 24
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Secondary outcome [5]
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Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis
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Assessment method [5]
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Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.
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Timepoint [5]
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From Baseline to Week 24
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Secondary outcome [6]
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Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
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Assessment method [6]
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Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [6]
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From Baseline to Week 24
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Secondary outcome [7]
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Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis
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Assessment method [7]
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Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
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Timepoint [7]
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From Baseline to Week 24
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Secondary outcome [8]
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Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis
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Assessment method [8]
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Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [8]
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From Baseline to Week 24
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Secondary outcome [9]
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Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis
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Assessment method [9]
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Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
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Timepoint [9]
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From Baseline to Week 24
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Secondary outcome [10]
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Percent Change From Baseline in Total-C at Week 24 - ITT Analysis
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Assessment method [10]
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Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [10]
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From Baseline to Week 24
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Secondary outcome [11]
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Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
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Assessment method [11]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [11]
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From Baseline to Week 24
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Secondary outcome [12]
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Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
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Assessment method [12]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [12]
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From Baseline to Week 24
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Secondary outcome [13]
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Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
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Assessment method [13]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [13]
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From Baseline to Week 24
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Secondary outcome [14]
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Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis
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Assessment method [14]
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Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) =1 and <5%.
High CV risk: 10-year fatal CVD risk SCORE =5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.
Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included.
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Timepoint [14]
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From Baseline to Week 24
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Secondary outcome [15]
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Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis
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Assessment method [15]
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Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
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Timepoint [15]
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From Baseline to Week 24
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Secondary outcome [16]
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Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis
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Assessment method [16]
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Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
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Timepoint [16]
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From Baseline to Week 24
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Secondary outcome [17]
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Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis
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Assessment method [17]
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Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).
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Timepoint [17]
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From Baseline to Week 24
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Secondary outcome [18]
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Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
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Assessment method [18]
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Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [18]
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From Baseline to Week 24
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Secondary outcome [19]
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Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
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Assessment method [19]
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Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
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Timepoint [19]
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From Baseline to Week 24
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Secondary outcome [20]
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Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
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Assessment method [20]
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Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [20]
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From Baseline to Week 24
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Secondary outcome [21]
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Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
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Assessment method [21]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [21]
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From Baseline to Week 24
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Secondary outcome [22]
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Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
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Assessment method [22]
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Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [22]
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From Baseline to Week 24
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Secondary outcome [23]
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Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
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Assessment method [23]
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Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [23]
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From Baseline to Week 24
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Secondary outcome [24]
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Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
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Assessment method [24]
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Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [24]
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From Baseline to Week 24
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Secondary outcome [25]
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Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
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Assessment method [25]
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Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.
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Timepoint [25]
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From Baseline to Week 24
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Eligibility
Key inclusion criteria
Inclusion criteria:
Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia
[heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or
fenofibrate) or diet alone.
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion criteria:
- LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very
high cardiovascular (CV) risk;
- LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at
high or moderate CV risk or, participants not fulfilling the statin intolerant
definition at moderate CV risk;
- LDL-C =160 mg/dL (=4.1 mmol/L) at screening for participants receiving diet only or,
participants not fulfilling the statin intolerant definition at moderate CV risk and
receiving a non-statin LMT.
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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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 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
16/12/2013
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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
30/06/2017
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Sample size
Target
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Accrual to date
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Final
233
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036703 - Ashford
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Recruitment hospital [2]
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Investigational Site Number 036702 - Perth
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Recruitment hospital [3]
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Investigational Site Number 036701 - Woolloongabba
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Recruitment postcode(s) [1]
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5035 - Ashford
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
0
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United States of America
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State/province [4]
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Missouri
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Country [5]
0
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United States of America
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State/province [5]
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North Carolina
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Country [6]
0
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United States of America
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State/province [6]
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South Carolina
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Antwerpen
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Country [8]
0
0
Belgium
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State/province [8]
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0
Haine-Saint-Paul
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Country [9]
0
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Belgium
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State/province [9]
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Leuven
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Country [10]
0
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Canada
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State/province [10]
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0
Chicoutimi
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Country [11]
0
0
Canada
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State/province [11]
0
0
Quebec
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Country [12]
0
0
Canada
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State/province [12]
0
0
Sherbrooke
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Country [13]
0
0
Canada
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State/province [13]
0
0
Toronto
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Country [14]
0
0
Canada
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State/province [14]
0
0
Vancouver
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Country [15]
0
0
Canada
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State/province [15]
0
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Victoria
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Country [16]
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Denmark
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State/province [16]
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Aarhus
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0
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Denmark
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State/province [17]
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Esbjerg
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Country [18]
0
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Denmark
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State/province [18]
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Glostrup
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Country [19]
0
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Denmark
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State/province [19]
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Hvidovre
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Country [20]
0
0
Denmark
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State/province [20]
0
0
Køge
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Country [21]
0
0
Netherlands
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State/province [21]
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0
Amsterdam
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Country [22]
0
0
Netherlands
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State/province [22]
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0
Den Helder
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Country [23]
0
0
Netherlands
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State/province [23]
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Hoogeveen
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Country [24]
0
0
Netherlands
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State/province [24]
0
0
Hoorn
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Country [25]
0
0
Netherlands
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State/province [25]
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Rotterdam
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Country [26]
0
0
Netherlands
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State/province [26]
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0
Sneek
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Country [27]
0
0
Netherlands
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State/province [27]
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0
Utrecht
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Country [28]
0
0
Netherlands
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State/province [28]
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Venlo
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Country [29]
0
0
New Zealand
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State/province [29]
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Auckland
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Country [30]
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New Zealand
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State/province [30]
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0
Christchurch
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Country [31]
0
0
Spain
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State/province [31]
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0
A Coruna
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Country [32]
0
0
Spain
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State/province [32]
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0
Barcelona
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Country [33]
0
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Spain
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State/province [33]
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Córdoba
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Country [34]
0
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Spain
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State/province [34]
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Granada
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Country [35]
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Spain
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State/province [35]
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Sant Joan Despí
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Country [36]
0
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Spain
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State/province [36]
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Santiago De Compostela
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Country [37]
0
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Spain
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State/province [37]
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Regeneron Pharmaceuticals
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of
Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin
lipid modifying background therapy or as monotherapy in comparison with placebo in
participants with primary hypercholesterolemia not treated with a statin.
Secondary Objective:
- To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus
placebo.
- To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.
Alirocumab 75 mg Q2W was added as a calibrator arm.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02023879
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Sciences & Operations
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Address
0
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Sanofi
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
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Country
0
0
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Phone
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Fax
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0
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02023879
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