Trial · NCT02715726
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
NCT02715726, Phase 3, Completed, Sanofi; results first posted 2019-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia. Trials, record NCT02715726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02715726
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
- NCT number
- NCT02715726
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 615 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Hypercholesterolemia
- Interventions
- Alirocumab, Placebo for alirocumab, ezetimibe, placebo for ezetimibe, atorvastatin, rosuvastatin, simvastatin
- First posted
- 2016-03-22
- Last updated
- 2019-09-30
- Results first posted
- 2019-09-30
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis). |
| Secondary | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis | From Baseline to Week 12 | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis | From Baseline to Week 12 | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis). |
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis | From Baseline to Week 24 | Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment. |
| Secondary | Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis | From Baseline to Week 12 | Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis | From Baseline to Week 24 | ITT population included 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 Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | From Baseline to Week 24 | Modified ITT (mITT) population included 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 Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis | From Baseline to Week 12 | ITT population. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis | From Baseline to Week 12 | 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 24 | 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 Apolipoprotein B at Week 24: On-Treatment Analysis | From Baseline to Week 24 | 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 24 | 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-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | From Baseline to Week 24 | 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 24 | Participants from 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 Apolipoprotein B at Week 12: ITT Analysis | From Baseline to Week 12 | Apo B ITT population. | percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group44
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 Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis | Ezetimibe 10 mg | -20.3 | Standard Error 2.0 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis | Alirocumab 75 mg Q2W/up to 150 mg Q2W | -56.0 | Standard Error 1.5 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | Ezetimibe 10 mg | -21.3 | Standard Error 2.0 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis | Alirocumab 75 mg Q2W/up to 150 mg Q2W | -58.7 | Standard Error 1.4 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis | Ezetimibe 10 mg | -22.2 | Standard Error 1.9 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis | Alirocumab 75 mg Q2W/up to 150 mg Q2W | -57.1 | Standard Error 1.4 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis | Ezetimibe 10 mg | -22.7 | Standard Error 1.9 | percent change | |
| Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis | Alirocumab 75 mg Q2W/up to 150 mg Q2W | -58.1 | Standard Error 1.4 | percent change | |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis | Ezetimibe 10 mg | -16.2 | Standard Error 1.4 | percent Change | |
| Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis | Alirocumab 75 mg Q2W/up to 150 mg Q2W | -43.5 | Standard Error 1.0 | percent Change |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe 10 mg | 208 | |
| Overall Study | STARTED | Alirocumab 75 mg Q2W/up to 150 mg Q2W | 407 | |
| Overall Study | Treated | Ezetimibe 10 mg | 207 | |
| Overall Study | Treated | Alirocumab 75 mg Q2W/up to 150 mg Q2W | 405 | |
| Overall Study | Safety Population | Ezetimibe 10 mg | 206 | |
| Overall Study | Safety Population | Alirocumab 75 mg Q2W/up to 150 mg Q2W | 406 | |
| Overall Study | COMPLETED | Ezetimibe 10 mg | 190 | |
| Overall Study | COMPLETED | Alirocumab 75 mg Q2W/up to 150 mg Q2W | 380 | |
| Overall Study | NOT COMPLETED | Ezetimibe 10 mg | 18 | |
| Overall Study | NOT COMPLETED | Alirocumab 75 mg Q2W/up to 150 mg Q2W | 27 |
Source ClinicalTrials.gov
Adverse events130
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 | Ezetimibe 10 mg | 29 | 206 | 39 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Alirocumab 75 mg Q2W/up150 mg Q2W | 54 | 406 | 69 |
| other | Accidental Overdose | Injury, poisoning and procedural complications | Ezetimibe 10 mg | 15 | 206 | 21 |
| other | Accidental Overdose | Injury, poisoning and procedural complications | Alirocumab 75 mg Q2W/up150 mg Q2W | 27 | 406 | 40 |
| serious | Acute Coronary Syndrome | Cardiac disorders | Ezetimibe 10 mg | 1 | 206 | 1 |
| serious | Acute Coronary Syndrome | Cardiac disorders | Alirocumab 75 mg Q2W/up150 mg Q2W | 1 | 406 | 1 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Ezetimibe 10 mg | 3 | 206 | 3 |
| serious | Acute Myocardial Infarction | Cardiac disorders | Alirocumab 75 mg Q2W/up150 mg Q2W | 3 | 406 | 3 |
| serious | Angina Unstable | Cardiac disorders | Ezetimibe 10 mg | 0 | 206 | 0 |
| serious | Angina Unstable | Cardiac disorders | Alirocumab 75 mg Q2W/up150 mg Q2W | 9 | 406 | 9 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ezetimibe 10 mg | 3 | 206 |
| Total, all-cause mortality | Alirocumab 75 mg Q2W/up150 mg Q2W | 2 | 406 |
| Total, other adverse events | Ezetimibe 10 mg | 41 | 206 |
| Total, other adverse events | Alirocumab 75 mg Q2W/up150 mg Q2W | 71 | 406 |
| Total, serious adverse events | Ezetimibe 10 mg | 23 | 206 |
| Total, serious adverse events | Alirocumab 75 mg Q2W/up150 mg Q2W | 41 | 406 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31882376 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ezetimibe 10 mg vs Alirocumab 75 mg Q2W/up150 mg Q2W: deaths from any cause | Trial comparisons |
| Ezetimibe 10 mg vs Alirocumab 75 mg Q2W/up150 mg Q2W: serious adverse events | 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.
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02715726
GET https://conductscience.org/api/trials/v1/NCT02715726/registered?page=2