Trial record 1 of 1 for:
efc11716
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia (ODYSSEY MONO)
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| ClinicalTrials.gov Identifier: NCT01644474 |
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Recruitment Status :
Completed
First Posted : July 19, 2012
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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| Study Type | Interventional |
|---|---|
| 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: Ezetimibe Drug: Placebo (for Alirocumab) Drug: Placebo (for Ezetimibe) |
| Enrollment | 103 |
Participant Flow
| Recruitment Details | The study was conducted at 8 centers in 4 countries. A total of 204 participants were screened between July 2012 and November 2012, 101 of whom were screen failures. Screen failures were mainly due to exclusion criteria met. |
| Pre-assignment Details | Randomization was stratified according to the diabetes mellitus status. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio ( alirocumab:ezetimibe) after confirmation of selection criteria. 103 participants were randomized. |
| Arm/Group Title | Ezetimibe 10 mg | Alirocumab 75/Up to 150 mg Q2W |
|---|---|---|
 Arm/Group Description |
Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks. | 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 low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| Period Title: Overall Study | ||
| Started | 51 [1] | 52 [1] |
| Treated | 51 | 52 |
| Completed | 44 | 44 |
| Not Completed | 7 | 8 |
| Reason Not Completed | ||
| Poor compliance to protocol | 1 | 0 |
| Consent withdrawn by participant | 0 | 1 |
| Participant moved | 0 | 1 |
| Adverse Event | 4 | 5 |
| Site scheduling error | 1 | 1 |
| Protocol Violation | 1 | 0 |
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[1]
Randomized
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Baseline Characteristics
| Arm/Group Title | Ezetimibe 10 mg | Alirocumab 75/Up to 150 mg Q2W | Total | |
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Arm/Group Description |
Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks. | 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. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 51 | 52 | 103 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| 59.6 (5.3) | 60.8 (4.6) | 60.2 (5.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| Female |
24 47.1%
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24 46.2%
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48 46.6%
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| Male |
27 52.9%
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28 53.8%
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55 53.4%
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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 | 51 participants | 52 participants | 103 participants | |
| 3.58 (0.6) | 3.65 (0.7) | 3.62 (0.7) | ||
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[1]
Measure Description: Calculated LDL-C in mmol/L from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/2.2]).
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Calculated LDL-C in mg/dL
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
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| Number Analyzed | 51 participants | 52 participants | 103 participants | |
| 138.3 (24.5) | 141.1 (27.1) | 139.7 (25.8) | ||
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[1]
Measure Description: Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]).
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Outcome Measures
Adverse Events
Limitations and Caveats
Due to administrative error in the automated process (which was detected after database lock), planned dose up-titration criteria for LDL-C levels was changed from ≥100 mg/dL to ≥70 mg/dL.
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
| Name/Title: | Trial Transparency Team |
| Organization: | Sanofi |
| EMail: | Contact-US@sanofi.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01644474 |
| Other Study ID Numbers: |
EFC11716 U1111-1124-1167 ( Other Identifier: UTN ) 2011-001424-38 ( EudraCT Number ) |
| First Submitted: | July 17, 2012 |
| First Posted: | July 19, 2012 |
| Results First Submitted: | August 20, 2015 |
| Results First Posted: | November 6, 2015 |
| Last Update Posted: | November 6, 2015 |