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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Alirocumab; Drug: Placebo (for alirocumab); Drug: Ezetimibe; Drug: Placebo (for ezetimibe); Drug: Lipid Modifying Therapy (LMT)	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	720 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	August 2012
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	July 2015

Arms and Interventions

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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: REGN727/SAR236553; Praluent 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: 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. 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.

Outcome Measures

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Primary Outcome Measures :

1. Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis [ Time Frame: From Baseline to Week 52 ]
   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 :

1. Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis [ Time Frame: From Baseline to Week 52 ]
   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).
2. Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
   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.
3. Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ]
   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).
4. Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
   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.
5. Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ]
   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).
6. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
   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.
7. Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline up to Week 52 ]
   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).
8. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
   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.
9. Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
   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.
10. Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
11. Percent Change From Baseline in Total-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
12. Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
13. Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis [ Time Frame: Up to Week 52 ]
    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.
14. Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis [ Time Frame: Up to Week 52 ]
    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).
15. Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis [ Time Frame: From baseline to Week 52 ]
    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.
16. Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
17. Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
18. Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
19. Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
20. Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
21. Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.
22. Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ]
    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.

Other Outcome Measures:

1. Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ]
   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).
2. Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis [ Time Frame: From Baseline to Week 104 ]
   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.
3. Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis [ Time Frame: From Baseline to Week 104 ]
   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).

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Sanofi

Regeneron Pharmaceuticals

Investigators

Study Director:	Clinical Sciences & Operations	Sanofi

More Information

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Publications of Results:

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2016 Oct 24.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01644188 History of Changes
Other Study ID Numbers:	EFC11569; U1111-1121-4315 ( Other Identifier: UTN ); 2011-004130-34 ( EudraCT Number )
First Posted:	July 18, 2012
Results First Posted:	November 6, 2015
Last Update Posted:	August 4, 2016
Last Verified:	June 2016

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Ezetimibe; Antibodies, Monoclonal	Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Immunologic Factors; Physiological Effects of Drugs