Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
NCT ID: NCT01644474
Last Updated: 2015-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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Primary Objective of the study:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia.
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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ezetimibe 10 mg
Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
Ezetimibe
One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
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.
Alirocumab 75/Up to 150 mg Q2W
SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
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.
Placebo (for Ezetimibe)
One capsule orally once daily at approximately the same time of the day with or without food..
Interventions
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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.
Ezetimibe
One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
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.
Placebo (for Ezetimibe)
One capsule orally once daily at approximately the same time of the day with or without food..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* LDL-C \< 100 mg/dL (\< 2.59 mmol/L) or \> 190 mg/dL (\> 4.9 mmol/L)
* Fasting serum triglycerides (TG) \> 400 mg/dL (\> 4.52 mmol/L)
* Known history of homozygous or heterozygous familial hypercholesterolemia
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840603
Overland Park, Kansas, United States
Investigational Site Number 840601
Cincinnati, Ohio, United States
Investigational Site Number 840602
Richmond, Virginia, United States
Investigational Site Number 056601
Antwerp, , Belgium
Investigational Site Number 246601
Helsinki, , Finland
Investigational Site Number 528602
Groningen, , Netherlands
Investigational Site Number 528601
Rotterdam, , Netherlands
Investigational Site Number 528603
Velp, , Netherlands
Countries
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References
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Roth EM, Taskinen MR, Ginsberg HN, Kastelein JJ, Colhoun HM, Robinson JG, Merlet L, Pordy R, Baccara-Dinet MT. Monotherapy with the PCSK9 inhibitor alirocumab versus ezetimibe in patients with hypercholesterolemia: results of a 24 week, double-blind, randomized Phase 3 trial. Int J Cardiol. 2014 Sep;176(1):55-61. doi: 10.1016/j.ijcard.2014.06.049. Epub 2014 Jul 2.
Roth EM, McKenney JM. ODYSSEY MONO: effect of alirocumab 75 mg subcutaneously every 2 weeks as monotherapy versus ezetimibe over 24 weeks. Future Cardiol. 2015;11(1):27-37. doi: 10.2217/fca.14.82.
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.
Other Identifiers
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U1111-1124-1167
Identifier Type: OTHER
Identifier Source: secondary_id
2011-001424-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EFC11716
Identifier Type: -
Identifier Source: org_study_id
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