Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
![]() |
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: NCT02023879 |
Recruitment Status :
Completed
First Posted : December 30, 2013
Results First Posted : March 15, 2017
Last Update Posted : July 27, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Hypercholesterolemia |
Interventions |
Drug: Alirocumab Drug: Placebo (for Alirocumab) Drug: Non-statin LMT Other: Diet Alone |
Enrollment | 233 |
Recruitment Details | The study was conducted at 43 centers in 8 countries. A total of 402 participants were screened between December-2013 and May-2014, of whom 233 were randomized for double-blind (DB) treatment period and 169 were screen failures. Out of 233 randomized for DB period, 205 participants entered the optional open-label (OL) extension period. |
Pre-assignment Details | Randomization was stratified by statin intolerant status & background therapy (non-statin lipid therapy vs diet). Randomization followed a 1:2:1 ratio for placebo, Alirocumab 75 mg and Alirocumab 150 mg instead of 1:1:2 as initially planned due to systematic error in treatment allocation algorithm discovered after all participants were randomized. |
Arm/Group Title | Placebo Q2W | Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator) | Alirocumab 150 mg Q4W/Up to 150 mg Q2W |
---|---|---|---|
![]() |
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks. Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed. |
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline. Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed. |
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline. Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed. |
Period Title: Period 1: 24-Week Double-blind Treatment | |||
Started | 58 | 116 | 59 |
Treated | 58 | 115 | 58 |
Completed | 54 | 107 | 50 |
Not Completed | 4 | 9 | 9 |
Reason Not Completed | |||
Adverse Event | 2 | 2 | 5 |
Poor compliance to protocol | 0 | 2 | 1 |
Physician Decision | 0 | 1 | 0 |
Consent withdrawn by participant | 1 | 0 | 1 |
Randomized but not treated | 0 | 1 | 1 |
Other than specified above | 1 | 3 | 1 |
Period Title: Extension Open Label Treatment | |||
Started | 51 [1] | 106 [1] | 48 [1] |
Completed | 46 | 89 | 43 |
Not Completed | 5 | 17 | 5 |
Reason Not Completed | |||
Adverse Event | 1 | 7 | 3 |
Poor compliance to protocol | 1 | 1 | 0 |
Participant moved | 1 | 2 | 0 |
Other than specified above | 2 | 7 | 2 |
[1]
The open-label extension period was optional for participants who completed the double-blind period.
|
Arm/Group Title | Placebo Q2W | Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator) | Alirocumab 150 mg Q4W/Up to 150 mg Q2W | Total | |
---|---|---|---|---|---|
![]() |
Period 1: Placebo (for Alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks. Period 2: Alirocumab 150 mg SC injection every 4 weeks (Q4W) from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Subsequent down titration to 150 mg Q4W was allowed. |
Period 1: Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline. Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed. |
Period 1: Alirocumab 150 mg SC injection Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline. Period 2: Alirocumab 150 mg SC injection Q4W from Week 24 until second quarter 2017 or until the drug is commercially available in the country, whatever occurred first. Alirocumab dose could be either up-titrated to 150 mg Q2W from Week 36 or maintained according to the investigator judgement and LDL-C values. Subsequent down titration to 150 mg Q4W was allowed. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 58 | 116 | 59 | 233 | |
![]() |
[Not Specified]
|
||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
63.1 (10.7) | 62.5 (9.9) | 64.2 (10.0) | 63.1 (10.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
Female |
27 46.6%
|
47 40.5%
|
29 49.2%
|
103 44.2%
|
|
Male |
31 53.4%
|
69 59.5%
|
30 50.8%
|
130 55.8%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
Hispanic or Latino |
1 1.7%
|
7 6.0%
|
4 6.8%
|
12 5.2%
|
|
Not Hispanic or Latino |
57 98.3%
|
109 94.0%
|
54 91.5%
|
220 94.4%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
1 1.7%
|
1 0.4%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
1 1.7%
|
4 3.4%
|
3 5.1%
|
8 3.4%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 0.9%
|
0 0.0%
|
1 0.4%
|
|
Black or African American |
1 1.7%
|
3 2.6%
|
1 1.7%
|
5 2.1%
|
|
White |
56 96.6%
|
108 93.1%
|
55 93.2%
|
219 94.0%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Calculated LDL-C in mg/dL
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
158.5 (47.3) | 154.5 (44.6) | 163.9 (69.1) | 157.9 (52.4) | ||
[1]
Measure Description: Calculated LDL-C from Friedewald formula (LDL-C = Total cholesterol [Total-C] - High-Density Lipoprotein Cholesterol [HDL-C] - [Triglyceride/5]).
|
|||||
Calculated LDL-C in mmol/L
Mean (Standard Deviation) Unit of measure: mmol/L |
|||||
Number Analyzed | 58 participants | 116 participants | 59 participants | 233 participants | |
4.106 (1.226) | 4.002 (1.154) | 4.245 (1.789) | 4.089 (1.356) |
Name/Title: | Trial Transparency Team |
Organization: | Sanofi |
EMail: | Contact-US@sanofi.com |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02023879 |
Other Study ID Numbers: |
EFC13786 2013-002659-14 ( EudraCT Number ) U1111-1146-3517 ( Other Identifier: UTN ) |
First Submitted: | December 6, 2013 |
First Posted: | December 30, 2013 |
Results First Submitted: | January 24, 2017 |
Results First Posted: | March 15, 2017 |
Last Update Posted: | July 27, 2018 |