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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/NCT01730053
Registration number
NCT01730053
Ethics application status
Date submitted
9/11/2012
Date registered
21/11/2012
Date last updated
7/04/2020
Titles & IDs
Public title
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
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Scientific title
A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin
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Secondary ID [1]
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0
R727-CL-1118
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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
0
0
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Condition category
Condition code
Metabolic and Endocrine
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0
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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 - Rosuvastatin
Treatment: Drugs - Ezetimibe
Treatment: Drugs - Placebo
Active Comparator: Rosuvastatin 20 mg - Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
Active Comparator: Ezetimibe 10 mg + Rosuvastatin 10 mg - Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Experimental: Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg - Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels =70 mg/dL (1.81 mmol/L) or =100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Active Comparator: Rosuvastatin 40 mg - Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
Active Comparator: Ezetimibe 10 mg + Rosuvastatin 20 mg - Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
Experimental: Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg - Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels =70 mg/dL (1.81 mmol/L) or =100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
Treatment: Drugs: Alirocumab
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Treatment: Drugs: Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Treatment: Drugs: Ezetimibe
Ezetimibe over-encapsulated tablets orally.
Treatment: Drugs: Placebo
Placebo for alirocumab and ezetimibe.
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Intervention code [1]
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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 Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
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Assessment method [1]
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Calculated LDL-C values were obtained from Friedewald formula. 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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Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (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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Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).
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Timepoint [2]
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From Baseline to Week 12
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Secondary outcome [3]
0
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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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Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained 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 or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
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Timepoint [3]
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From Baseline to Week 12
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Secondary outcome [4]
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Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
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Assessment method [4]
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Adjusted LS means and standard errors at Week 24 from MMRM 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 [4]
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0
From Baseline to Week 24
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Secondary outcome [5]
0
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Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
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Assessment method [5]
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Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).
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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 Non-High-density Lipoprotein Cholesterol (Non-HDL-C) 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 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 [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 Non-HDL-C 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 were obtained 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 or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).
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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 Total Cholesterol (Total-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 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 [8]
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From Baseline to Week 24
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Secondary outcome [9]
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0
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
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Assessment method [9]
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Adjusted LS means and standard errors at Week 12 from MMRM 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 [9]
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From Baseline to Week 12
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Secondary outcome [10]
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Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
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Assessment method [10]
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Adjusted LS means and standard errors at Week 12 from MMRM 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 [10]
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From Baseline to Week 12
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Secondary outcome [11]
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Percent Change From Baseline in Total-C 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 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 [11]
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From Baseline to Week 12
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Secondary outcome [12]
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Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
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Assessment method [12]
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Calculated LDL-C values were obtained from Friedewald formula. 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 in the imputation model (ITT analysis).
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Timepoint [12]
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Up to Week 24
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Secondary outcome [13]
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Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
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Assessment method [13]
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Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
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Timepoint [13]
0
0
Up to Week 24
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Secondary outcome [14]
0
0
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
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Assessment method [14]
0
0
Calculated LDL-C values were obtained from Friedewald formula. 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 in the imputation model (ITT analysis).
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Timepoint [14]
0
0
Up to Week 24
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Secondary outcome [15]
0
0
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
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Assessment method [15]
0
0
Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
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Timepoint [15]
0
0
Up to Week 24
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Secondary outcome [16]
0
0
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
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Assessment method [16]
0
0
Adjusted means and standard errors at Week 24 from a multiple imputation approach 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 [16]
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0
From Baseline to Week 24
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Secondary outcome [17]
0
0
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
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Assessment method [17]
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Adjusted LS means and standard errors at Week 24 from MMRM 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 [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 Fasting Triglycerides 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 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 Apo A-1 at Week 24 - ITT Analysis
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Assessment method [19]
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Adjusted LS means and standard errors at Week 24 from MMRM 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]
0
0
From Baseline to Week 24
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Secondary outcome [20]
0
0
Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
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Assessment method [20]
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0
Adjusted means and standard errors at Week 12 from a multiple imputation approach 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 [20]
0
0
From Baseline to Week 12
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Secondary outcome [21]
0
0
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
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Assessment method [21]
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0
Adjusted LS means and standard errors at Week 12 from MMRM 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 [21]
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0
From Baseline to Week 12
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Secondary outcome [22]
0
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Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
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Assessment method [22]
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0
Adjusted means and standard errors at Week 12 from a multiple imputation approach 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 12
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Secondary outcome [23]
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Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
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Assessment method [23]
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Adjusted LS means and standard errors at Week 12 from MMRM 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 12
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Eligibility
Key inclusion criteria
1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who
are not adequately controlled with a stable daily dose of rosuvastatin, with or
without other LMT.
OR
2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not
adequately controlled with a stable daily dose of rosuvastatin before the screening
visit, with or without other LMT.
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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
1. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented
cardiovascular disease (CVD)
2. LDL-C less than 100 mg/dL at the screening visit in patients without history of
documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors
3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI),
unstable angina leading to hospitalization, percutaneous coronary intervention (PCI),
coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke,
transient ischemic attack, carotid revascularization, endovascular procedure or
surgical intervention for peripheral vascular disease
5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled
diabetes
6. Presence of any clinically significant uncontrolled endocrine disease known to
influence serum lipids or lipoproteins
(The inclusion/ exclusion criteria provided above is not intended to contain all
considerations relevant to a patient's potential participation in this 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 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
30/11/2012
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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
31/05/2014
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Sample size
Target
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Accrual to date
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Final
305
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Herston
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Recruitment hospital [2]
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- New Lambton Heights
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Recruitment hospital [3]
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- Perth
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Recruitment hospital [4]
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- Sherwood
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Recruitment hospital [5]
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- Woolloongabba
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Recruitment postcode(s) [1]
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- Herston
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Recruitment postcode(s) [2]
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- New Lambton Heights
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Recruitment postcode(s) [3]
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- Perth
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Recruitment postcode(s) [4]
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- Sherwood
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Recruitment postcode(s) [5]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Arizona
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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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California
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0
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United States of America
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State/province [3]
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Connecticut
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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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Florida
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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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Idaho
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Country [6]
0
0
United States of America
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State/province [6]
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Illinois
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Country [7]
0
0
United States of America
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State/province [7]
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Indiana
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Country [8]
0
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United States of America
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State/province [8]
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Kansas
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United States of America
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State/province [9]
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Kentucky
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United States of America
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State/province [10]
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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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Minnesota
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United States of America
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Mississippi
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United States of America
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Missouri
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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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New York
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United States of America
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Ohio
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United States of America
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State/province [18]
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Oregon
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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Canada
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Ontario
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Canada
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Quebec
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France
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Dijon
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France
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Lille
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Germany
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Bad Oeynhausen
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Germany
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Berlin
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Germany
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Koeln
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Germany
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Regensburg
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Germany
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Ulm
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Italy
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State/province [33]
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Chieti
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Italy
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Genova
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Roma
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Mexico
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Baja California
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Mexico
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Distrito Federal
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Zapopan Jalisco
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santiago
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Spain
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Sevilla
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United Kingdom
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West Midlands
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United Kingdom
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Chester
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0
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United Kingdom
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Peterborough
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United Kingdom
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Salford
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United Kingdom
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Stevenage
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Regeneron Pharmaceuticals
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Address
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Country
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Other collaborator category [1]
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Sanofi
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Summary
Brief summary
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab
(REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia
at high cardiovascular (CV) risk.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01730053
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Contacts
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Clinical Trial Management
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Regeneron Pharmaceuticals
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01730053
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