Trial record 1 of 1 for:
EFC14074 | Studies With Results | Phase 3
Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan
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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: NCT02289963 |
Recruitment Status :
Completed
First Posted : November 13, 2014
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
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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 | 199 |
Participant Flow
Recruitment Details | The study was conducted at 27 centers in South Korea and Taiwan. Overall 316 participants were screened between January and September 2015, of whom 117 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, intensity of statin treatment and country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (Placebo:Alirocumab). A total of 199 participants were randomized. |
Arm/Group Title | Placebo Q2W | Alirocumab 75 mg Q2W/Up to 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 24 weeks. | Alirocumab 75 mg SC injection Q2W 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) levels ≥70 mg/dL (1.81 mmol/L) at Week 8. |
Period Title: Overall Study | ||
Started | 102 [1] | 97 [1] |
Treated | 102 | 97 |
Completed | 97 | 87 |
Not Completed | 5 | 10 |
Reason Not Completed | ||
Adverse Event | 1 | 2 |
Poor compliance to protocol | 1 | 0 |
Withdrawal by Subject | 1 | 0 |
Last injection missed | 2 | 2 |
End treatment visit outside visit window | 0 | 4 |
Other than specified above | 0 | 2 |
[1]
Randomized
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Baseline Characteristics
Arm/Group Title | Placebo Q2W | Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Total | |
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Placebo (for alirocumab) SC injection Q2W added to stable LMT for 24 weeks. | Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W 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 | 102 | 97 | 199 | |
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Baseline population included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 102 participants | 97 participants | 199 participants | |
60.1 (9.1) | 61.2 (10.4) | 60.6 (9.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 102 participants | 97 participants | 199 participants | |
Female |
21 20.6%
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14 14.4%
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35 17.6%
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Male |
81 79.4%
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83 85.6%
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164 82.4%
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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 | 102 participants | 97 participants | 199 participants | |
2.572 (0.653) | 2.513 (0.721) | 2.543 (0.686) | ||
[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.
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: | NCT02289963 |
Other Study ID Numbers: |
EFC14074 U1111-1157-3294 ( Other Identifier: UTN ) |
First Submitted: | November 10, 2014 |
First Posted: | November 13, 2014 |
Results First Submitted: | April 24, 2017 |
Results First Posted: | June 26, 2017 |
Last Update Posted: | June 26, 2017 |