Trial record 2 of 2 for:
efc12492
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH 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: NCT01623115 |
Recruitment Status :
Completed
First Posted : June 19, 2012
Results First Posted : November 4, 2015
Last Update Posted : February 8, 2016
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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: Lipid Modifying Therapy (LMT) |
Enrollment | 486 |
Participant Flow
Recruitment Details | The study was conducted at 89 centers in 14 countries. A total of 597 participants were screened between July 2012 and April 2013, 111 of whom were screen failures. |
Pre-assignment Details | Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, intensity of statin treatment & geographic region. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:2 (placebo:alirocumab) after confirmation of selection criteria. 486 participants were randomized. |
Arm/Group Title | Placebo | Alirocumab 75 mg/Up to 150 mg Q2W |
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Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks. | Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 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 | 163 [1] | 323 [1] |
Treated | 163 | 322 |
Completed | 130 | 246 |
Not Completed | 33 | 77 |
Reason Not Completed | ||
Randomized but not treated | 0 | 1 |
Physician Decision | 1 | 0 |
Participants moved | 1 | 5 |
Adverse Event | 10 | 13 |
Poor compliance to protocol | 4 | 10 |
Consent withdrawn by participant | 2 | 6 |
Related to study drug administration | 0 | 2 |
Last visit outside protocol visit window | 14 | 26 |
Site closure | 1 | 7 |
Death | 0 | 4 |
Other than specified above | 0 | 3 |
[1]
Randomized
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Baseline Characteristics
Arm/Group Title | Placebo | Alirocumab 75 mg/Up to 150 mg Q2W | Total | |
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Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks. | Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 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 | 163 | 323 | 486 | |
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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 | 163 participants | 323 participants | 486 participants | |
51.7 (12.3) | 52.1 (12.9) | 51.9 (12.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 163 participants | 323 participants | 486 participants | |
Female |
69 42.3%
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143 44.3%
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212 43.6%
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Male |
94 57.7%
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180 55.7%
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274 56.4%
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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 | 163 participants | 323 participants | 486 participants | |
144.4 (46.8) | 144.8 (51.1) | 144.6 (49.7) | ||
[1]
Measure Description: Calculated LDL-C from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]).
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Calculated LDL-C in mmol/L
Mean (Standard Deviation) Unit of measure: mmol/L |
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Number Analyzed | 163 participants | 323 participants | 486 participants | |
3.739 (1.213) | 3.749 (1.325) | 3.746 (1.287) |
Outcome Measures
Adverse Events
Limitations and Caveats
Manual reclassification was done by the Sponsor for the "other reasons" of non-completion of study as specified in the electronic case report form (eCRF).
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: | NCT01623115 |
Other Study ID Numbers: |
EFC12492 U1111-1121-4275 ( Other Identifier: UTN ) 2011-005109-56 ( EudraCT Number ) |
First Submitted: | June 15, 2012 |
First Posted: | June 19, 2012 |
Results First Submitted: | August 20, 2015 |
Results First Posted: | November 4, 2015 |
Last Update Posted: | February 8, 2016 |