Trial record 1 of 1 for:
EFC13889
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY EAST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02715726 |
Recruitment Status :
Completed
First Posted : March 22, 2016
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Hypercholesterolemia |
Interventions |
Drug: Alirocumab Drug: Placebo for alirocumab Drug: ezetimibe Drug: placebo for ezetimibe Drug: atorvastatin Drug: rosuvastatin Drug: simvastatin |
Enrollment | 615 |
Participant Flow
Recruitment Details | The study was conducted at 61 centers in China, India and Thailand. Overall 1163 participants were screened between 27 July 2016 and 18 December 2017, of whom 548 were screen failures. Screen failures were mainly due to exclusion criteria met. A total of 615 participants were randomized in 2:1 ratio to alirocumab: ezetimibe. |
Pre-assignment Details | Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke [Yes/No], and high-intensity statin treatment (Yes: atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily, no: atorvastatin below 40 mg daily, rosuvastatin below 20 mg daily or simvastatin whatever the dose daily) and country. |
Arm/Group Title | Ezetimibe 10 mg | Alirocumab 75 mg Q2W/up to 150 mg Q2W |
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Oral ezetimibe 10 mg capsule once daily with or without food for 24 Weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT). | Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) level was >=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]) at Week 8. |
Period Title: Overall Study | ||
Started | 208 [1] | 407 [1] |
Treated | 207 | 405 |
Safety Population [2] | 206 | 406 |
Completed | 190 | 380 |
Not Completed | 18 | 27 |
Reason Not Completed | ||
Adverse Event | 2 | 6 |
Protocol Violation | 1 | 0 |
Death | 2 | 1 |
Participant moved | 1 | 3 |
Other than specified above | 11 | 15 |
Randomized but not treated | 1 | 2 |
[1]
Randomized
[2]
1 participant of ezetimibe arm received alirocumab: counted in alirocumab arm for safety analysis.
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Baseline Characteristics
Arm/Group Title | Ezetimibe 10 mg | Alirocumab 75 mg Q2W/up to 150 mg Q2W | Total | |
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Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT. | Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8. | Total of all reporting groups | |
Overall Number of Baseline Participants | 208 | 407 | 615 | |
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Analysis was performed on randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 208 participants | 407 participants | 615 participants | |
58.3 (11.2) | 58.8 (10.7) | 58.6 (10.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 208 participants | 407 participants | 615 participants | |
Female |
62 29.8%
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92 22.6%
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154 25.0%
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Male |
146 70.2%
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315 77.4%
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461 75.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 208 participants | 407 participants | 615 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
208 100.0%
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407 100.0%
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615 100.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
0 0.0%
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0 0.0%
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0 0.0%
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White |
0 0.0%
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0 0.0%
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0 0.0%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Calculated LDL-C in mmol/L
[1] Mean (Standard Deviation) Unit of measure: mmol/L |
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Number Analyzed | 208 participants | 407 participants | 615 participants | |
2.875 (1.287) | 2.862 (1.253) | 2.866 (1.264) | ||
[1]
Measure Description: Calculated LDL-C in mmol/L from Friedewald formula (LDL-C = Total cholesterol - High-density lipoprotein cholesterol [HDL-C] - [Triglyceride/2.2]).
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi aventis recherche & développement |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02715726 |
Other Study ID Numbers: |
EFC13889 U1111-1150-8859 ( Other Identifier: UTN ) |
First Submitted: | March 16, 2016 |
First Posted: | March 22, 2016 |
Results First Submitted: | August 5, 2019 |
Results First Posted: | September 30, 2019 |
Last Update Posted: | September 30, 2019 |