Trial · NCT01644188
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
NCT01644188, Phase 3, Completed, Sanofi; results first posted 2015-11-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II). Trials, record NCT01644188. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01644188
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
- NCT number
- NCT01644188
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 720 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Hypercholesterolemia
- Interventions
- Alirocumab, Placebo (for alirocumab), Ezetimibe, Placebo (for ezetimibe), Lipid Modifying Therapy (LMT)
- First posted
- 2012-07-18
- Last updated
- 2016-08-04
- Other registries' IDs
- eudract:2011-004130-34
- Results first posted
- 2015-11-06
- 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).
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 52 | Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis). |
| Secondary | Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline up to Week 52 | Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). |
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis | From Baseline to Week 52 | Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | From Baseline to Week 52 | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | From Baseline to Week 52 | Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | From Baseline to Week 52 | ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | From Baseline to Week 52 | mITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | From Baseline to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | From Baseline up to Week 52 | Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | From Baseline to Week 52 | Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis | From Baseline to Week 52 | Apo-B ITT population. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Alirocumab 75 /up to 150 mg Q2W | -50.6 | Standard Error 1.4 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | Ezetimibe 10 mg | -20.7 | Standard Error 1.9 | percent change | |
| Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | Alirocumab 75 /up to 150 mg Q2W | -52.4 | Standard Error 1.3 | percent change | |
| Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | Ezetimibe 10 mg | -21.8 | Standard Error 1.8 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Alirocumab 75 /up to 150 mg Q2W | -51.2 | Standard Error 1.3 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Ezetimibe 10 mg | -21.8 | Standard Error 1.8 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Alirocumab 75 /up to 150 mg Q2W | -52.4 | Standard Error 1.2 | percent change | |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | Ezetimibe 10 mg | -22.7 | Standard Error 1.7 | percent change | |
| Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | Alirocumab 75 /up to 150 mg Q2W | -40.7 | Standard Error 1.1 | percent change | |
| Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | Ezetimibe 10 mg | -18.3 | Standard Error 1.5 | percent change |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alirocumab 75 /up to 150 mg Q2W | 479 | |
| Overall Study | STARTED | Ezetimibe 10 mg | 241 | |
| Overall Study | Treated | Alirocumab 75 /up to 150 mg Q2W | 479 | |
| Overall Study | Treated | Ezetimibe 10 mg | 241 | |
| Overall Study | COMPLETED | Alirocumab 75 /up to 150 mg Q2W | 357 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg | 166 | |
| Overall Study | NOT COMPLETED | Alirocumab 75 /up to 150 mg Q2W | 122 | |
| Overall Study | NOT COMPLETED | Ezetimibe 10 mg | 75 |
Source ClinicalTrials.gov
Adverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Alirocumab 75/Up to 150 mg Q2W | 42 | 479 | |
| other | Upper respiratory tract infection | Infections and infestations | Ezetimibe 10 mg | 17 | 241 | |
| other | Nasopharyngitis | Infections and infestations | Alirocumab 75/Up to 150 mg Q2W | 23 | 479 | |
| other | Nasopharyngitis | Infections and infestations | Ezetimibe 10 mg | 15 | 241 | |
| other | Influenza | Infections and infestations | Alirocumab 75/Up to 150 mg Q2W | 22 | 479 | |
| other | Influenza | Infections and infestations | Ezetimibe 10 mg | 16 | 241 | |
| other | Dizziness | Nervous system disorders | Alirocumab 75/Up to 150 mg Q2W | 28 | 479 | |
| other | Dizziness | Nervous system disorders | Ezetimibe 10 mg | 18 | 241 | |
| other | Headache | Nervous system disorders | Alirocumab 75/Up to 150 mg Q2W | 29 | 479 | |
| other | Headache | Nervous system disorders | Ezetimibe 10 mg | 13 | 241 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alirocumab 75/Up to 150 mg Q2W | ||
| Total, all-cause mortality | Ezetimibe 10 mg | ||
| Total, other adverse events | Alirocumab 75/Up to 150 mg Q2W | 185 | 479 |
| Total, other adverse events | Ezetimibe 10 mg | 90 | 241 |
| Total, serious adverse events | Alirocumab 75/Up to 150 mg Q2W | 124 | 479 |
| Total, serious adverse events | Ezetimibe 10 mg | 60 | 241 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Alirocumab 75/Up to 150 mg Q2W vs Ezetimibe 10 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01644188
GET https://conductscience.org/api/trials/v1/NCT01644188/registered?page=2