Trial record 1 of 1 for:
efc11568
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
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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: NCT01644175 |
Recruitment Status :
Completed
First Posted : July 18, 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 |
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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: Placebo (for alirocumab) Drug: Alirocumab Drug: Lipid-Modifying Therapy (LMT) |
Enrollment | 316 |
Participant Flow
Recruitment Details | The study was conducted at 76 centers in the United States of America. Overall, 640 participants were screened between July 2012 and February 2013, 324 of whom were screen failures. Screen failures were mainly due to exclusion criteria met. |
Pre-assignment Details | Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo: alirocumab) after confirmation of selection criteria. 316 participants were randomized. |
Arm/Group Title | Placebo Q2W | Alirocumab 75/150 mg Q2W |
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Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks. | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 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. |
Period Title: Overall Study | ||
Started | 107 [1] | 209 [1] |
Treated | 107 | 207 |
Completed | 75 | 156 |
Not Completed | 32 | 53 |
Reason Not Completed | ||
Randomized But Not Treated | 0 | 2 |
Adverse Event | 8 | 13 |
Death | 1 | 2 |
Poor compliance to protocol | 9 | 10 |
Physician Decision | 1 | 2 |
Participant Moved | 1 | 2 |
Consent withdrawn by participant | 3 | 4 |
Related to Autoinjector Administration | 2 | 1 |
Last visit outside protocol visit window | 4 | 11 |
Selection criteria finally not met | 0 | 1 |
Site closure | 2 | 2 |
Lost to Follow-up | 1 | 0 |
Other than specified above | 0 | 3 |
[1]
Randomized
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Baseline Characteristics
Arm/Group Title | Placebo Q2W | Alirocumab 75/150 mg Q2W | Total | |
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Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. | Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 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 | 107 | 209 | 316 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 107 participants | 209 participants | 316 participants | |
63.0 (8.8) | 63.0 (9.5) | 63.0 (9.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 107 participants | 209 participants | 316 participants | |
Female |
30 28.0%
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78 37.3%
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108 34.2%
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Male |
77 72.0%
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131 62.7%
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208 65.8%
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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 | 107 participants | 209 participants | 316 participants | |
2.746 (0.915) | 2.595 (0.764) | 2.646 (0.820) | ||
[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 | 107 participants | 209 participants | 316 participants | |
106.0 (35.3) | 100.2 (29.5) | 102.2 (31.6) | ||
[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
[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.
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01644175 |
Other Study ID Numbers: |
EFC11568 U1111-1121-4356 ( Other Identifier: UTN ) |
First Submitted: | July 16, 2012 |
First Posted: | July 18, 2012 |
Results First Submitted: | August 20, 2015 |
Results First Posted: | November 6, 2015 |
Last Update Posted: | November 6, 2015 |