Trial record 1 of 1 for:
dfi11566
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
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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: NCT01288469 |
Recruitment Status :
Completed
First Posted : February 2, 2011
Results First Posted : September 24, 2015
Last Update Posted : September 24, 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: Alirocumab Drug: Placebo (for alirocumab) Drug: Atorvastatin Drug: Placebo (for atorvastatin) |
Enrollment | 92 |
Participant Flow
Recruitment Details | The study was conducted at 20 centers in the United States of America. Overall, 214 participants were screened between January 2011 and April 2011. Screen failures were mainly due to exclusion criteria met. |
Pre-assignment Details | Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1 ratio after confirmation of selection criteria. 92 participants were randomized. |
Arm/Group Title | Placebo + Atorvastatin 80 mg | Alirocumab + Atorvastatin 10 mg | Alirocumab + Atorvastatin 80 mg |
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Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks. | Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks. | Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks. |
Period Title: Overall Study | |||
Started | 31 [1] | 31 [1] | 30 [1] |
Treated | 31 | 31 | 30 |
Completed | 24 | 28 | 28 |
Not Completed | 7 | 3 | 2 |
Reason Not Completed | |||
Adverse Event | 4 | 1 | 1 |
Poor compliance to protocol | 0 | 1 | 0 |
Participant Moved | 1 | 0 | 0 |
Consent withdrawn by subject | 1 | 1 | 1 |
Exclusion criteria finally met | 1 | 0 | 0 |
[1]
Randomized
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Baseline Characteristics
Arm/Group Title | Placebo + Atorvastatin 80 mg | Alirocumab + Atorvastatin 10 mg | Alirocumab + Atorvastatin 80 mg | Total | |
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Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks. | Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks. | Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 31 | 31 | 30 | 92 | |
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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 | 31 participants | 31 participants | 30 participants | 92 participants | |
55.3 (10.3) | 57.9 (10.0) | 57.6 (9.3) | 56.9 (9.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 30 participants | 92 participants | |
Female |
18 58.1%
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17 54.8%
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20 66.7%
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55 59.8%
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Male |
13 41.9%
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14 45.2%
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10 33.3%
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37 40.2%
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Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L
Mean (Standard Deviation) Unit of measure: mmol/L |
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Number Analyzed | 31 participants | 31 participants | 30 participants | 92 participants | |
3.138 (0.469) | 3.101 (0.402) | 3.288 (0.564) | 3.174 (0.484) | ||
LDL-C in mg/dL
Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 31 participants | 31 participants | 30 participants | 92 participants | |
121.2 (18.1) | 119.7 (15.5) | 126.9 (21.8) | 122.6 (18.7) |
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 of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01288469 |
Other Study ID Numbers: |
DFI11566 U1111-1117-9994 ( Other Identifier: UTN ) |
First Submitted: | February 1, 2011 |
First Posted: | February 2, 2011 |
Results First Submitted: | August 21, 2015 |
Results First Posted: | September 24, 2015 |
Last Update Posted: | September 24, 2015 |