Trial record 1 of 1 for:
EFC14305
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin (ODYSSEY-NIPPON)
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ClinicalTrials.gov Identifier: NCT02584504 |
Recruitment Status :
Completed
First Posted : October 22, 2015
Results First Posted : May 7, 2018
Last Update Posted : January 23, 2019
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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 Drug: Atorvastatin Drug: Non-statin Lipid-Modifying Therapy Other: Diet Alone |
Enrollment | 163 |
Participant Flow
Recruitment Details | The study was conducted at 30 active centers in Japan. Overall 241 participants were screened between 30 November 2015 and 19 October 2016, of whom 78 were screen failures and 163 were randomized. Screen failures were mainly due to exclusion criteria met. |
Pre-assignment Details | Randomization stratified per background statin therapy (Yes/No). "No statin" also stratified per background fibrate/ezetimibe therapy (Yes/No), 'Yes' =fibrate/ezetimibe, 'No' =diet therapy alone. Randomization followed 1:1:1 ratio (Alirocumab 150 mg Q4W: Alirocumab 150 mg Q2W: Placebo Q2W). |
Arm/Group Title | Alirocumab 150 mg Q4W | Alirocumab 150 mg Q2W | Placebo Q2W |
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In double-blind treatment period (DBTP), participants received Alirocumab 150 mg subcutaneous (SC) injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to lowest-strength statin therapy (atorvastatin 5 mg daily), stable non-statin Lipid-Modifying Therapy (LMT) or diet therapy alone for 12 weeks. Participants who completed DBTP, entered in open-label treatment period (OLTP) and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg every 2 weeks (Q2W) at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. | In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. | In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. |
Period Title: Double-blind Treatment | |||
Started | 54 [1] | 53 [1] | 56 [1] |
ITT Population | 54 | 53 | 56 |
mITT Population | 54 | 53 | 56 |
Safety Population | 54 | 53 | 56 |
Completed | 54 | 51 | 55 |
Not Completed | 0 | 2 | 1 |
Reason Not Completed | |||
Participant withdrew consent | 0 | 0 | 1 |
Adverse Event | 0 | 1 | 0 |
Family Matter | 0 | 1 | 0 |
[1]
Randomized
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Period Title: Open-label Treatment | |||
Started | 54 | 51 | 55 |
Treated | 54 | 50 | 54 |
Completed | 52 | 47 | 47 |
Not Completed | 2 | 4 | 8 |
Reason Not Completed | |||
Participant withdrew consent | 0 | 0 | 4 |
Adverse Event | 2 | 2 | 3 |
Physician Decision | 0 | 1 | 0 |
Entered but not treated | 0 | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Alirocumab 150 mg Q4W | Alirocumab 150 mg Q2W | Placebo Q2W | Total | |
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In DBTP, participants received Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to lowest-strength of statin therapy (atorvastatin 5 mg daily), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. | In DBTP, participants received Alirocumab 150 mg SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. | In DBTP, participants received Placebo (for alirocumab) SC injection Q2W added to lowest-strength statin therapy (atorvastatin 5 mg), stable non-statin LMT or diet therapy alone for 12 weeks. Participants who completed DBTP were entered in OLTP and received alirocumab 150 mg Q4W up to additional 52 weeks (up to Week 64). Alirocumab dose up-titrated to 150 mg Q2W at Week 24 (Week 12 of OLTP), when LDL-C levels ≥100 mg/dL (2.59 mmol/L) or ≥120 mg/dL (3.10 mmol/L) at Week 20 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. | Total of all reporting groups | |
Overall Number of Baseline Participants | 54 | 53 | 56 | 163 | |
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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 | 54 participants | 53 participants | 56 participants | 163 participants | |
62.6 (9.8) | 63.6 (10.4) | 64.6 (10.0) | 63.6 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 54 participants | 53 participants | 56 participants | 163 participants | |
Female |
21 38.9%
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20 37.7%
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19 33.9%
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60 36.8%
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Male |
33 61.1%
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33 62.3%
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37 66.1%
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103 63.2%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Asian | Number Analyzed | 54 participants | 53 participants | 56 participants | 163 participants |
54 100.0%
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53 100.0%
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56 100.0%
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163 100.0%
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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 | 54 participants | 53 participants | 56 participants | 163 participants | |
154.2 (59.5) | 149.2 (31.1) | 149.4 (32.6) | 150.9 (42.8) | ||
[1]
Measure Description: Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - high density lipoprotein [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 | 54 participants | 53 participants | 56 participants | 163 participants | |
3.993 (1.541) | 3.865 (0.806) | 3.870 (0.844) | 3.909 (1.109) |
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 |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02584504 |
Other Study ID Numbers: |
EFC14305 U1111-1170-7697 ( Other Identifier: UTN ) |
First Submitted: | October 21, 2015 |
First Posted: | October 22, 2015 |
Results First Submitted: | April 3, 2018 |
Results First Posted: | May 7, 2018 |
Last Update Posted: | January 23, 2019 |