Back to resultsStudy of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alirocumab
Atorvastatin
Ezetimibe
Rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
- Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.
Exclusion Criteria:
- LDL-C greater than 250 mg/dL
- LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
- LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
- TG greater than 400 mg/dL
- Homozygous FH (clinically or previous genotyping)
- Currently taking a statin that is not atorvastatin
- Currently taking Ezetimibe (EZE)
- Not on a stable dose of allowable lipid modifying treatments (LMT)
(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Active Comparator
Active Comparator
Experimental
Active Comparator
Active Comparator
Active Comparator
Experimental
Arm Label
Atorvastatin 40 mg
Ezetimibe 10 mg + Atorvastatin 20 mg
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Atorvastatin 80 mg
Rosuvastatin 40 mg
Ezetimibe 10 mg + Atorvastatin 40 mg
Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
Arm Description
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
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).
Secondary Outcome Measures
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
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 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
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).
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
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.
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
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).
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
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
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).
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from 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.
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 from 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.
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
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.
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from 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.
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
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.
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Adjusted means and standard errors at Week 12 from 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.
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
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.
Full Information
NCT ID
NCT01730040
First Posted
November 9, 2012
Last Updated
July 29, 2015
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT01730040
Brief Title
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
Official Title
A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
Arm Title
Ezetimibe 10 mg + Atorvastatin 20 mg
Arm Type
Active Comparator
Arm Description
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Arm Title
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Arm Type
Experimental
Arm Description
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
Arm Title
Atorvastatin 80 mg
Arm Type
Active Comparator
Arm Description
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Arm Title
Rosuvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Arm Title
Ezetimibe 10 mg + Atorvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Arm Title
Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
Arm Type
Experimental
Arm Description
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets 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.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
REGN727/SAR236553
Intervention Description
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin over-encapsulated tablets orally.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Ezetrol
Intervention Description
Ezetimibe over-encapsulated tablet orally.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
Rosuvastatin over-encapsulated tablets orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for alirocumab and ezetimibe.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
Description
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).
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Description
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 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Description
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).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Description
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Description
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Description
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first).
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
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
Description
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).
Time Frame
Up to Week 24
Title
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
Description
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
Time Frame
Up to Week 24
Title
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Description
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).
Time Frame
Up to Week 24
Title
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Description
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 atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).
Time Frame
Up to Week 24
Title
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Description
Adjusted means and standard errors at Week 24 from 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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Description
Adjusted means and standard errors at Week 24 from 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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
Description
Adjusted means and standard errors at Week 12 from 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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Description
Adjusted means and standard errors at Week 12 from 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.
Time Frame
From Baseline to Week 24
Title
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
Description
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.
Time Frame
From Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.
Exclusion Criteria:
LDL-C greater than 250 mg/dL
LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
TG greater than 400 mg/dL
Homozygous FH (clinically or previous genotyping)
Currently taking a statin that is not atorvastatin
Currently taking Ezetimibe (EZE)
Not on a stable dose of allowable lipid modifying treatments (LMT)
(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Chandler
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Lakeland
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
Northridge
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Walnut Creek
State/Province
California
Country
United States
City
Milford
State/Province
Connecticut
Country
United States
City
Atlantis
State/Province
Florida
Country
United States
City
Boca Raton
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Miami (2 locations)
State/Province
Florida
Country
United States
City
Oviedo
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Port Orange
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Meridian
State/Province
Idaho
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Morton
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Newton
State/Province
Kansas
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Wichita
State/Province
Kansas
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Auburn
State/Province
Maine
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Port Gibson
State/Province
Mississippi
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Warwick
State/Province
Rhode Island
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Summerville
State/Province
South Carolina
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Dallas (2 locations)
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Bountiful
State/Province
Utah
Country
United States
City
Marion
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Renton
State/Province
Washington
Country
United States
City
Herston QLD
Country
Australia
City
New Lambton Heights
Country
Australia
City
Perth
Country
Australia
City
Sherwood
Country
Australia
City
Woolloongabba
Country
Australia
City
Brampton
State/Province
Ontario
Country
Canada
City
Etobicoke
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Newmarke
State/Province
Ontario
Country
Canada
City
Thornhill
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Chicoutimi
State/Province
Quebec
Country
Canada
City
Dijon
Country
France
City
Lille
Country
France
City
Venissieux
Country
France
City
Bad Oeynhausen
Country
Germany
City
Berlin
Country
Germany
City
Koeln
Country
Germany
City
Munich
Country
Germany
City
Regensburg
Country
Germany
City
Ulm
Country
Germany
City
Chiete
Country
Italy
City
Genova
Country
Italy
City
Napoli
Country
Italy
City
Palermo
Country
Italy
City
Roma (2 locations)
Country
Italy
City
Distrito Federal
Country
Mexico
City
Guadalajara, Jalisco
Country
Mexico
City
Guadalajara
Country
Mexico
City
Monterrey Nuevo Leon
Country
Mexico
City
Tijuana Baja California
Country
Mexico
City
Zapopan Jalisco
Country
Mexico
City
Barcelona (3 locations)
Country
Spain
City
Madrid
Country
Spain
City
Sant Joan Despi
Country
Spain
City
Carmarthen
Country
United Kingdom
City
Chester
Country
United Kingdom
City
Peterborough
Country
United Kingdom
City
Salford
Country
United Kingdom
City
Stevenage
Country
United Kingdom
City
West Bromwich, West Midlands
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34298554
Citation
Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.
Results Reference
derived
PubMed Identifier
30183102
Citation
Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.
Results Reference
derived
PubMed Identifier
27777279
Citation
Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.
Results Reference
derived
PubMed Identifier
26030325
Citation
Bays H, Gaudet D, Weiss R, Ruiz JL, Watts GF, Gouni-Berthold I, Robinson J, Zhao J, Hanotin C, Donahue S. Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3140-8. doi: 10.1210/jc.2015-1520. Epub 2015 Jun 1.
Results Reference
derived
PubMed Identifier
25269777
Citation
Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.
Results Reference
derived
Learn more about this trial
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
We'll reach out to this number within 24 hrs