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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alirocumab
Placebo (for alirocumab)
Ezetimibe
Placebo (for ezetimibe)
Lipid Modifying Therapy (LMT)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever was greater
  • Participants without established CHD or CHD risk equivalents
  • LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
  • LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 840980
  • Investigational Site Number 840918
  • Investigational Site Number 840925
  • Investigational Site Number 840959
  • Investigational Site Number 840301
  • Investigational Site Number 840933
  • Investigational Site Number 840991
  • Investigational Site Number 840979
  • Investigational Site Number 840952
  • Investigational Site Number 840930
  • Investigational Site Number 840921
  • Investigational Site Number 840962
  • Investigational Site Number 840987
  • Investigational Site Number 840302
  • Investigational Site Number 840935
  • Investigational Site Number 840903
  • Investigational Site Number 840920
  • Investigational Site Number 840943
  • Investigational Site Number 840981
  • Investigational Site Number 840961
  • Investigational Site Number 840303
  • Investigational Site Number 840986
  • Investigational Site Number 840988
  • Investigational Site Number 840995
  • Investigational Site Number 840902
  • Investigational Site Number 840960
  • Investigational Site Number 840940
  • Investigational Site Number 840966
  • Investigational Site Number 840917
  • Investigational Site Number 840998
  • Investigational Site Number 840946
  • Investigational Site Number 840914
  • Investigational Site Number 840949
  • Investigational Site Number 840974
  • Investigational Site Number 840955
  • Investigational Site Number 840938
  • Investigational Site Number 840976
  • Investigational Site Number 840985
  • Investigational Site Number 840963
  • Investigational Site Number 840970
  • Investigational Site Number 840906
  • Investigational Site Number 840997
  • Investigational Site Number 840964
  • Investigational Site Number 840913
  • Investigational Site Number 840912
  • Investigational Site Number 840992
  • Investigational Site Number 840932
  • Investigational Site Number 840944
  • Investigational Site Number 840994
  • Investigational Site Number 840973
  • Investigational Site Number 840939
  • Investigational Site Number 840945
  • Investigational Site Number 840971
  • Investigational Site Number 840982
  • Investigational Site Number 840931
  • Investigational Site Number 840984
  • Investigational Site Number 840928
  • Investigational Site Number 840990
  • Investigational Site Number 124902
  • Investigational Site Number 124914
  • Investigational Site Number 124903
  • Investigational Site Number 124918
  • Investigational Site Number 208913
  • Investigational Site Number 208914
  • Investigational Site Number 208905
  • Investigational Site Number 208911
  • Investigational Site Number 208907
  • Investigational Site Number 208901
  • Investigational Site Number 208906
  • Investigational Site Number 208908
  • Investigational Site Number 208903
  • Investigational Site Number 250906
  • Investigational Site Number 250907
  • Investigational Site Number 250903
  • Investigational Site Number 250905
  • Investigational Site Number 348908
  • Investigational Site Number 348901
  • Investigational Site Number 348903
  • Investigational Site Number 348905
  • Investigational Site Number 348906
  • Investigational Site Number 376908
  • Investigational Site Number 376903
  • Investigational Site Number 376906
  • Investigational Site Number 376902
  • Investigational Site Number 376904
  • Investigational Site Number 376907
  • Investigational Site Number 376901
  • Investigational Site Number 410908
  • Investigational Site Number 410920
  • Investigational Site Number 410926
  • Investigational Site Number 410923
  • Investigational Site Number 410909
  • Investigational Site Number 410922
  • Investigational Site Number 410921
  • Investigational Site Number 410905
  • Investigational Site Number 410901
  • Investigational Site Number 410914
  • Investigational Site Number 410924
  • Investigational Site Number 410915
  • Investigational Site Number 410913
  • Investigational Site Number 410927
  • Investigational Site Number 643906
  • Investigational Site Number 643903
  • Investigational Site Number 643927
  • Investigational Site Number 643928
  • Investigational Site Number 643931
  • Investigational Site Number 643924
  • Investigational Site Number 643932
  • Investigational Site Number 643908
  • Investigational Site Number 643904
  • Investigational Site Number 643911
  • Investigational Site Number 643921
  • Investigational Site Number 643925
  • Investigational Site Number 643922
  • Investigational Site Number 643929
  • Investigational Site Number 643914
  • Investigational Site Number 710917
  • Investigational Site Number 710909
  • Investigational Site Number 710914
  • Investigational Site Number 710905
  • Investigational Site Number 710904
  • Investigational Site Number 710918
  • Investigational Site Number 710913
  • Investigational Site Number 710915
  • Investigational Site Number 804905
  • Investigational Site Number 804902

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Alirocumab 75 /up to 150 mg Q2W

Ezetimibe 10 mg

Arm Description

Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.

Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
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 52 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
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 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Percent Change From Baseline in Apolipoprotein B (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 52 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 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, 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 52 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 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, 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 52 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 52 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 52 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 52 regardless of status on- or off-treatment.
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
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 52 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 multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Percent Change From Baseline in Apolipoprotein A-1 (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 52 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 multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 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 52 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 multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 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 52 regardless of status on- or off-treatment.

Full Information

First Posted
July 16, 2012
Last Updated
June 23, 2016
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01644188
Brief Title
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Official Title
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points To evaluate the effect of alirocumab on other lipid parameters To evaluate the safety and tolerability of alirocumab
Detailed Description
The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

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
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alirocumab 75 /up to 150 mg Q2W
Arm Type
Experimental
Arm Description
Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
Arm Title
Ezetimibe 10 mg
Arm Type
Active Comparator
Arm Description
Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
REGN727/SAR236553, Praluent
Intervention Description
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Intervention Type
Drug
Intervention Name(s)
Placebo (for alirocumab)
Intervention Description
1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
Intervention Type
Drug
Intervention Name(s)
Placebo (for ezetimibe)
Intervention Description
One capsule once daily orally at approximately the same time of the day with or without food.
Intervention Type
Drug
Intervention Name(s)
Lipid Modifying Therapy (LMT)
Intervention Description
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
Description
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 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame
From Baseline to Week 52
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL--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 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Description
Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Apolipoprotein B (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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline up to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Description
Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Description
Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.
Time Frame
Up to Week 52
Title
Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
Description
Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
Up to Week 52
Title
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
Description
Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.
Time Frame
From baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Description
Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Apolipoprotein A-1 (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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
Description
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Description
Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
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 52 regardless of status on- or off-treatment.
Time Frame
From Baseline to Week 52
Other Pre-specified Outcome Measures:
Title
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline to Week 52
Title
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis
Description
Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.
Time Frame
From Baseline to Week 104
Title
Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis
Description
Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
Time Frame
From Baseline to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2). Exclusion criteria: Age < 18 or legal age of adulthood, whichever was greater Participants without established CHD or CHD risk equivalents LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840980
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Investigational Site Number 840918
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigational Site Number 840925
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Investigational Site Number 840959
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Investigational Site Number 840301
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Investigational Site Number 840933
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Investigational Site Number 840991
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Investigational Site Number 840979
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Investigational Site Number 840952
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Investigational Site Number 840930
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Investigational Site Number 840921
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
Investigational Site Number 840962
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Investigational Site Number 840987
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Investigational Site Number 840302
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Site Number 840935
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Investigational Site Number 840903
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Investigational Site Number 840920
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigational Site Number 840943
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Investigational Site Number 840981
City
Oveido
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Investigational Site Number 840961
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Investigational Site Number 840303
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number 840986
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Investigational Site Number 840988
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Investigational Site Number 840995
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Investigational Site Number 840902
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Investigational Site Number 840960
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Investigational Site Number 840940
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Investigational Site Number 840966
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Investigational Site Number 840917
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Investigational Site Number 840998
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Investigational Site Number 840946
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site Number 840914
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Investigational Site Number 840949
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Investigational Site Number 840974
City
New Windsor
State/Province
New York
ZIP/Postal Code
12553
Country
United States
Facility Name
Investigational Site Number 840955
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigational Site Number 840938
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27292
Country
United States
Facility Name
Investigational Site Number 840976
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States
Facility Name
Investigational Site Number 840985
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Investigational Site Number 840963
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Investigational Site Number 840970
City
Lyndhust
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Investigational Site Number 840906
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Investigational Site Number 840997
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Investigational Site Number 840964
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Investigational Site Number 840913
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Investigational Site Number 840912
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Investigational Site Number 840992
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Investigational Site Number 840932
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Investigational Site Number 840944
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Investigational Site Number 840994
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Investigational Site Number 840973
City
Houston
State/Province
Texas
ZIP/Postal Code
77070
Country
United States
Facility Name
Investigational Site Number 840939
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Investigational Site Number 840945
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Investigational Site Number 840971
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigational Site Number 840982
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Investigational Site Number 840931
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Investigational Site Number 840984
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23227
Country
United States
Facility Name
Investigational Site Number 840928
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Investigational Site Number 840990
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Investigational Site Number 124902
City
Brampton
ZIP/Postal Code
L6T 3J1
Country
Canada
Facility Name
Investigational Site Number 124914
City
Mirabel
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Investigational Site Number 124903
City
Montreal
ZIP/Postal Code
H1T 3Y7
Country
Canada
Facility Name
Investigational Site Number 124918
City
Toronto
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Investigational Site Number 208913
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number 208914
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Investigational Site Number 208905
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Investigational Site Number 208911
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Investigational Site Number 208907
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Investigational Site Number 208901
City
København S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Investigational Site Number 208906
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Facility Name
Investigational Site Number 208908
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigational Site Number 208903
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Investigational Site Number 250906
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Investigational Site Number 250907
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250903
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 250905
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Investigational Site Number 348908
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Investigational Site Number 348901
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 348903
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Investigational Site Number 348905
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Investigational Site Number 348906
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Investigational Site Number 376908
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Investigational Site Number 376903
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Investigational Site Number 376906
City
Ofakim
ZIP/Postal Code
80300
Country
Israel
Facility Name
Investigational Site Number 376902
City
Petach Tikva
Country
Israel
Facility Name
Investigational Site Number 376904
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Investigational Site Number 376907
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Investigational Site Number 376901
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Investigational Site Number 410908
City
Anyang-Si
ZIP/Postal Code
431-070
Country
Korea, Republic of
Facility Name
Investigational Site Number 410920
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Investigational Site Number 410926
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Investigational Site Number 410923
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Investigational Site Number 410909
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Investigational Site Number 410922
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Investigational Site Number 410921
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Investigational Site Number 410905
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Investigational Site Number 410901
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Investigational Site Number 410914
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Investigational Site Number 410924
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Investigational Site Number 410915
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Investigational Site Number 410913
City
Uijeongbu
ZIP/Postal Code
480-717
Country
Korea, Republic of
Facility Name
Investigational Site Number 410927
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Investigational Site Number 643906
City
Barnaul
ZIP/Postal Code
656055
Country
Russian Federation
Facility Name
Investigational Site Number 643903
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Investigational Site Number 643927
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site Number 643928
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site Number 643931
City
Moscow
ZIP/Postal Code
115404
Country
Russian Federation
Facility Name
Investigational Site Number 643924
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Investigational Site Number 643932
City
Moscow
ZIP/Postal Code
121374
Country
Russian Federation
Facility Name
Investigational Site Number 643908
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 643904
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Investigational Site Number 643911
City
Orenburg
ZIP/Postal Code
450000
Country
Russian Federation
Facility Name
Investigational Site Number 643921
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Investigational Site Number 643925
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number 643922
City
Saint-Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Investigational Site Number 643929
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Investigational Site Number 643914
City
St-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Investigational Site Number 710917
City
Alberton
ZIP/Postal Code
1450
Country
South Africa
Facility Name
Investigational Site Number 710909
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710914
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710905
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 710904
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Investigational Site Number 710918
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Facility Name
Investigational Site Number 710913
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Investigational Site Number 710915
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 804905
City
Kiev
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Investigational Site Number 804902
City
Uzhhorod
ZIP/Postal Code
88009
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25240705
Citation
Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.
Results Reference
background
PubMed Identifier
25687353
Citation
Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16.
Results Reference
result
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

Learn more about this trial

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

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