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

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Ezetimibe; Drug: Alirocumab; Drug: Placebo (for ezetimibe); Drug: Lipid Modifying Therapy (LMT); Drug: Placebo (for 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.

• Study Type: Interventional
• Enrollment (Actual): 720
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Brampton, Canada, L6T 3J1
    • Investigational Site Number 124902
  • Mirabel, Canada, J7J 2K8
    • Investigational Site Number 124914
  • Montreal, Canada, H1T 3Y7
    • Investigational Site Number 124903
  • Toronto, Canada, M9V 4B4
    • Investigational Site Number 124918
• Denmark
  • Esbjerg, Denmark, 6700
    • Investigational Site Number 208913
  • Glostrup, Denmark, 2600
    • Investigational Site Number 208914
  • Hellerup, Denmark, 2900
    • Investigational Site Number 208905
  • Herlev, Denmark, 2730
    • Investigational Site Number 208911
  • Hvidovre, Denmark, 2650
    • Investigational Site Number 208907
  • København S, Denmark, 2300
    • Investigational Site Number 208901
  • Køge, Denmark, 4600
    • Investigational Site Number 208906
  • Roskilde, Denmark, 4000
    • Investigational Site Number 208908
  • Silkeborg, Denmark, 8600
    • Investigational Site Number 208903
• France
  • Dijon, France, 21079
    • Investigational Site Number 250906
  • Montpellier Cedex 5, France, 34295
    • Investigational Site Number 250907
  • Nantes, France, 44093
    • Investigational Site Number 250903
  • Nimes, France, 30900
    • Investigational Site Number 250905
• Hungary
  • Budapest, Hungary, 1036
    • Investigational Site Number 348908
  • Budapest, Hungary, 1134
    • Investigational Site Number 348901
  • Budapest, Hungary, 1134
    • Investigational Site Number 348903
  • Debrecen, Hungary, 4032
    • Investigational Site Number 348905
  • Szekesfehervar, Hungary, 8000
    • Investigational Site Number 348906
• Israel
  • Holon, Israel, 58100
    • Investigational Site Number 376908
  • Kfar Saba, Israel, 44281
    • Investigational Site Number 376903
  • Ofakim, Israel, 80300
    • Investigational Site Number 376906
  • Petach Tikva, Israel
    • Investigational Site Number 376902
  • Rehovot, Israel, 76100
    • Investigational Site Number 376904
  • Safed, Israel, 13100
    • Investigational Site Number 376907
  • Tel Aviv, Israel, 64239
    • Investigational Site Number 376901
• Korea, Republic of
  • Anyang-Si, Korea, Republic of, 431-070
    • Investigational Site Number 410908
  • Busan, Korea, Republic of, 602-715
    • Investigational Site Number 410920
  • Daegu, Korea, Republic of, 700-712
    • Investigational Site Number 410926
  • Gwangju, Korea, Republic of, 501-757
    • Investigational Site Number 410923
  • Seoul, Korea, Republic of, 110-744
    • Investigational Site Number 410909
  • Seoul, Korea, Republic of, 120-752
    • Investigational Site Number 410922
  • Seoul, Korea, Republic of, 135-710
    • Investigational Site Number 410921
  • Seoul, Korea, Republic of, 135-720
    • Investigational Site Number 410905
  • Seoul, Korea, Republic of, 137-701
    • Investigational Site Number 410901
  • Seoul, Korea, Republic of, 138-736
    • Investigational Site Number 410914
  • Seoul, Korea, Republic of, 156-707
    • Investigational Site Number 410924
  • Suwon, Korea, Republic of, 443-721
    • Investigational Site Number 410915
  • Uijeongbu, Korea, Republic of, 480-717
    • Investigational Site Number 410913
  • Wonju, Korea, Republic of, 220-701
    • Investigational Site Number 410927
• Russian Federation
  • Barnaul, Russian Federation, 656055
    • Investigational Site Number 643906
  • Kemerovo, Russian Federation, 650002
    • Investigational Site Number 643903
  • Moscow, Russian Federation, 111539
    • Investigational Site Number 643927
  • Moscow, Russian Federation, 111539
    • Investigational Site Number 643928
  • Moscow, Russian Federation, 115404
    • Investigational Site Number 643931
  • Moscow, Russian Federation, 119048
    • Investigational Site Number 643924
  • Moscow, Russian Federation, 121374
    • Investigational Site Number 643932
  • Moscow, Russian Federation, 121552
    • Investigational Site Number 643908
  • Moscow, Russian Federation, 129090
    • Investigational Site Number 643904
  • Orenburg, Russian Federation, 450000
    • Investigational Site Number 643911
  • Ryazan, Russian Federation, 390026
    • Investigational Site Number 643921
  • Saint-Petersburg, Russian Federation, 197110
    • Investigational Site Number 643925
  • Saint-Petersburg, Russian Federation, 198205
    • Investigational Site Number 643922
  • Saratov, Russian Federation, 410028
    • Investigational Site Number 643929
  • St-Petersburg, Russian Federation, 199106
    • Investigational Site Number 643914
• South Africa
  • Alberton, South Africa, 1450
    • Investigational Site Number 710917
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 710909
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 710914
  • Cape Town, South Africa, 7500
    • Investigational Site Number 710905
  • Cape Town, South Africa, 7925
    • Investigational Site Number 710904
  • Middelburg, South Africa, 1055
    • Investigational Site Number 710918
  • Pretoria, South Africa, 0002
    • Investigational Site Number 710913
  • Somerset West, South Africa, 7130
    • Investigational Site Number 710915
• Ukraine
  • Kiev, Ukraine, 02091
    • Investigational Site Number 804905
  • Uzhhorod, Ukraine, 88009
    • Investigational Site Number 804902
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Investigational Site Number 840980
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Investigational Site Number 840918
    • Tucson, Arizona, United States
      • Investigational Site Number 840925
  • California
    • Anaheim, California, United States, 92801
      • Investigational Site Number 840959
    • Beverly Hills, California, United States, 90211
      • Investigational Site Number 840301
    • Chino, California, United States, 91710
      • Investigational Site Number 840933
    • Lincoln, California, United States, 95648
      • Investigational Site Number 840991
    • Los Angeles, California, United States, 90057
      • Investigational Site Number 840979
    • Palm Springs, California, United States, 92262
      • Investigational Site Number 840952
    • Thousand Oaks, California, United States, 91360
      • Investigational Site Number 840930
    • Vista, California, United States, 92083
      • Investigational Site Number 840921
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Investigational Site Number 840962
    • Bradenton, Florida, United States, 34203
      • Investigational Site Number 840987
    • Clearwater, Florida, United States, 33756
      • Investigational Site Number 840302
    • Jacksonville, Florida, United States, 32223
      • Investigational Site Number 840935
    • Miami, Florida, United States, 33126
      • Investigational Site Number 840903
    • Miami, Florida, United States
      • Investigational Site Number 840920
    • Ocala, Florida, United States, 34471
      • Investigational Site Number 840943
    • Oveido, Florida, United States, 32765
      • Investigational Site Number 840981
    • Port Orange, Florida, United States, 32127
      • Investigational Site Number 840961
    • Sarasota, Florida, United States, 34239
      • Investigational Site Number 840303
    • St. Petersburg, Florida, United States
      • Investigational Site Number 840986
    • St. Petersburg, Florida, United States
      • Investigational Site Number 840988
  • Idaho
    • Meridian, Idaho, United States, 83646
      • Investigational Site Number 840995
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Investigational Site Number 840902
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Investigational Site Number 840960
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • Investigational Site Number 840940
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Investigational Site Number 840966
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Investigational Site Number 840917
    • St. Louis, Missouri, United States, 63131
      • Investigational Site Number 840998
  • Montana
    • Butte, Montana, United States, 59701
      • Investigational Site Number 840946
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Investigational Site Number 840914
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Investigational Site Number 840949
  • New York
    • New Windsor, New York, United States, 12553
      • Investigational Site Number 840974
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Investigational Site Number 840955
    • Lexington, North Carolina, United States, 27292
      • Investigational Site Number 840938
    • Smithfield, North Carolina, United States, 27577
      • Investigational Site Number 840976
    • Winston-Salem, North Carolina, United States, 27103
      • Investigational Site Number 840985
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Investigational Site Number 840963
    • Lyndhust, Ohio, United States, 44124
      • Investigational Site Number 840970
    • Marion, Ohio, United States, 43302
      • Investigational Site Number 840906
    • Marion, Ohio, United States, 43302
      • Investigational Site Number 840997
    • Perrysburg, Ohio, United States, 43551
      • Investigational Site Number 840964
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Investigational Site Number 840913
    • Greer, South Carolina, United States, 29651
      • Investigational Site Number 840912
    • Summerville, South Carolina, United States, 29485
      • Investigational Site Number 840992
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Investigational Site Number 840932
    • Nashville, Tennessee, United States, 37205
      • Investigational Site Number 840944
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Investigational Site Number 840994
    • Houston, Texas, United States, 77070
      • Investigational Site Number 840973
    • Houston, Texas, United States, 77074
      • Investigational Site Number 840939
    • Sugar Land, Texas, United States, 77479
      • Investigational Site Number 840945
    • Tomball, Texas, United States, 77375
      • Investigational Site Number 840971
  • Utah
    • Orem, Utah, United States, 84058
      • Investigational Site Number 840982
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Investigational Site Number 840931
    • Richmond, Virginia, United States, 23227
      • Investigational Site Number 840984
  • Washington
    • Renton, Washington, United States, 98055
      • Investigational Site Number 840928
    • Spokane, Washington, United States, 99204
      • Investigational Site Number 840990

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alirocumab 75 /up to 150 mg Q2W; 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.	Drug: Alirocumab; 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.; Other Names: Praluent; REGN727/SAR236553; Drug: Placebo (for ezetimibe); One capsule once daily orally at approximately the same time of the day with or without food.; Drug: Lipid Modifying Therapy (LMT); Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
Active Comparator: Ezetimibe 10 mg; Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.	Drug: Ezetimibe; One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.; Drug: Lipid Modifying Therapy (LMT); Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.; Drug: Placebo (for alirocumab); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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).	From Baseline to Week 52
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.	From Baseline to Week 52
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).	From Baseline to Week 52
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.	From Baseline to Week 52
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).	From Baseline to Week 52
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).	From Baseline up to Week 52
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.	From Baseline to Week 52
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.	From Baseline to Week 52
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.	Up to Week 52
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).	Up to Week 52
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.	From Baseline to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis	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).	From Baseline to Week 52
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis	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.	From Baseline to Week 104
Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis	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).	From Baseline to Week 104

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: July 16, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Immunologic Factors; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Antibodies, Monoclonal; Ezetimibe
• Other Study ID Numbers: EFC11569; U1111-1121-4315 (Other Identifier: UTN); 2011-004130-34 (EudraCT Number)