Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-4315 | Other Identifier | UTN | |
| 2011-004130-34 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.
Secondary Objectives:
The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alirocumab 75 /up to 150 mg Q2W | Experimental | Alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8. |
|
| Ezetimibe 10 mg | Active Comparator | Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | 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). | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | 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). | From Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 52 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). | From Baseline to Week 52 |
Inclusion criteria:
Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840980 | Birmingham | Alabama | 35209 | United States | ||
| Investigational Site Number 840918 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25240705 | Background | Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121. | |
| 25687353 |
Not provided
Not provided
Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, intensity of statin treatment and geographical region. Assignment to arms was done centrally using Interactive Voice/Web Response System in 2:1 ratio (alirocumab: ezetimibe) after confirmation of selection criteria. 720 participants were randomized.
The study was conducted at 126 centers in 10 countries. Overall, 1112 participants were screened between August 2012 and May 2013, 392 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Alirocumab 75 /up to 150 mg Q2W | Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid- Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo (for alirocumab) | Drug | 1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector. |
|
| Ezetimibe | Drug | One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food. |
|
| Placebo (for ezetimibe) | Drug | One capsule once daily orally at approximately the same time of the day with or without food. |
|
| Lipid Modifying Therapy (LMT) | Drug | Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose. |
|
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | 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). | From Baseline to Week 52 |
| Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | 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). | From Baseline to Week 52 |
| Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | 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). | From Baseline up to Week 52 |
| Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model. | Up to Week 52 |
| Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach 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). | Up to Week 52 |
| Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | From baseline to Week 52 |
| Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | From Baseline to Week 52 |
| Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | 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. | From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis |
Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment. |
| From Baseline to Week 104 |
| Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). | From Baseline to Week 104 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Investigational Site Number 840925 | Tucson | Arizona | United States |
| Investigational Site Number 840959 | Anaheim | California | 92801 | United States |
| Investigational Site Number 840301 | Beverly Hills | California | 90211 | United States |
| Investigational Site Number 840933 | Chino | California | 91710 | United States |
| Investigational Site Number 840991 | Lincoln | California | 95648 | United States |
| Investigational Site Number 840979 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 840952 | Palm Springs | California | 92262 | United States |
| Investigational Site Number 840930 | Thousand Oaks | California | 91360 | United States |
| Investigational Site Number 840921 | Vista | California | 92083 | United States |
| Investigational Site Number 840962 | Boynton Beach | Florida | 33472 | United States |
| Investigational Site Number 840987 | Bradenton | Florida | 34203 | United States |
| Investigational Site Number 840302 | Clearwater | Florida | 33756 | United States |
| Investigational Site Number 840935 | Jacksonville | Florida | 32223 | United States |
| Investigational Site Number 840903 | Miami | Florida | 33126 | United States |
| Investigational Site Number 840920 | Miami | Florida | United States |
| Investigational Site Number 840943 | Ocala | Florida | 34471 | United States |
| Investigational Site Number 840981 | Oveido | Florida | 32765 | United States |
| Investigational Site Number 840961 | Port Orange | Florida | 32127 | United States |
| Investigational Site Number 840303 | Sarasota | Florida | 34239 | United States |
| Investigational Site Number 840986 | St. Petersburg | Florida | United States |
| Investigational Site Number 840988 | St. Petersburg | Florida | United States |
| Investigational Site Number 840995 | Meridian | Idaho | 83646 | United States |
| Investigational Site Number 840902 | Evansville | Indiana | 47714 | United States |
| Investigational Site Number 840960 | Topeka | Kansas | 66606 | United States |
| Investigational Site Number 840940 | Oxon Hill | Maryland | 20745 | United States |
| Investigational Site Number 840966 | Fall River | Massachusetts | 02720 | United States |
| Investigational Site Number 840917 | Kansas City | Missouri | 64114 | United States |
| Investigational Site Number 840998 | St Louis | Missouri | 63131 | United States |
| Investigational Site Number 840946 | Butte | Montana | 59701 | United States |
| Investigational Site Number 840914 | Lincoln | Nebraska | 68510 | United States |
| Investigational Site Number 840949 | Albuquerque | New Mexico | 87106 | United States |
| Investigational Site Number 840974 | New Windsor | New York | 12553 | United States |
| Investigational Site Number 840955 | Greenville | North Carolina | 27834 | United States |
| Investigational Site Number 840938 | Lexington | North Carolina | 27292 | United States |
| Investigational Site Number 840976 | Smithfield | North Carolina | 27577 | United States |
| Investigational Site Number 840985 | Winston-Salem | North Carolina | 27103 | United States |
| Investigational Site Number 840963 | Cincinnati | Ohio | 45219 | United States |
| Investigational Site Number 840970 | Lyndhust | Ohio | 44124 | United States |
| Investigational Site Number 840906 | Marion | Ohio | 43302 | United States |
| Investigational Site Number 840997 | Marion | Ohio | 43302 | United States |
| Investigational Site Number 840964 | Perrysburg | Ohio | 43551 | United States |
| Investigational Site Number 840913 | Charleston | South Carolina | 29412 | United States |
| Investigational Site Number 840912 | Greer | South Carolina | 29651 | United States |
| Investigational Site Number 840992 | Summerville | South Carolina | 29485 | United States |
| Investigational Site Number 840932 | Bristol | Tennessee | 37620 | United States |
| Investigational Site Number 840944 | Nashville | Tennessee | 37205 | United States |
| Investigational Site Number 840994 | Fort Worth | Texas | 76104 | United States |
| Investigational Site Number 840973 | Houston | Texas | 77070 | United States |
| Investigational Site Number 840939 | Houston | Texas | 77074 | United States |
| Investigational Site Number 840945 | Sugar Land | Texas | 77479 | United States |
| Investigational Site Number 840971 | Tomball | Texas | 77375 | United States |
| Investigational Site Number 840982 | Orem | Utah | 84058 | United States |
| Investigational Site Number 840931 | Norfolk | Virginia | 23502 | United States |
| Investigational Site Number 840984 | Richmond | Virginia | 23227 | United States |
| Investigational Site Number 840928 | Renton | Washington | 98055 | United States |
| Investigational Site Number 840990 | Spokane | Washington | 99204 | United States |
| Investigational Site Number 124902 | Brampton | L6T 3J1 | Canada |
| Investigational Site Number 124914 | Mirabel | J7J 2K8 | Canada |
| Investigational Site Number 124903 | Montreal | H1T 3Y7 | Canada |
| Investigational Site Number 124918 | Toronto | M9V 4B4 | Canada |
| Investigational Site Number 208913 | Esbjerg | 6700 | Denmark |
| Investigational Site Number 208914 | Glostrup Municipality | 2600 | Denmark |
| Investigational Site Number 208905 | Hellerup | 2900 | Denmark |
| Investigational Site Number 208911 | Herlev | 2730 | Denmark |
| Investigational Site Number 208907 | Hvidovre | 2650 | Denmark |
| Investigational Site Number 208901 | København S | 2300 | Denmark |
| Investigational Site Number 208906 | Køge | 4600 | Denmark |
| Investigational Site Number 208908 | Roskilde | 4000 | Denmark |
| Investigational Site Number 208903 | Silkeborg | 8600 | Denmark |
| Investigational Site Number 250906 | Dijon | 21079 | France |
| Investigational Site Number 250907 | Montpellier | 34295 | France |
| Investigational Site Number 250903 | Nantes | 44093 | France |
| Investigational Site Number 250905 | Nîmes | 30900 | France |
| Investigational Site Number 348908 | Budapest | 1036 | Hungary |
| Investigational Site Number 348901 | Budapest | 1134 | Hungary |
| Investigational Site Number 348903 | Budapest | 1134 | Hungary |
| Investigational Site Number 348905 | Debrecen | 4032 | Hungary |
| Investigational Site Number 348906 | Székesfehérvár | 8000 | Hungary |
| Investigational Site Number 376908 | Holon | 58100 | Israel |
| Investigational Site Number 376903 | Kfar Saba | 44281 | Israel |
| Investigational Site Number 376906 | Ofakim | 80300 | Israel |
| Investigational Site Number 376902 | Petah Tikva | Israel |
| Investigational Site Number 376904 | Rehovot | 76100 | Israel |
| Investigational Site Number 376907 | Safed | 13100 | Israel |
| Investigational Site Number 376901 | Tel Aviv | 64239 | Israel |
| Investigational Site Number 643906 | Barnaul | 656055 | Russia |
| Investigational Site Number 643903 | Kemerovo | 650002 | Russia |
| Investigational Site Number 643927 | Moscow | 111539 | Russia |
| Investigational Site Number 643928 | Moscow | 111539 | Russia |
| Investigational Site Number 643931 | Moscow | 115404 | Russia |
| Investigational Site Number 643924 | Moscow | 119048 | Russia |
| Investigational Site Number 643932 | Moscow | 121374 | Russia |
| Investigational Site Number 643908 | Moscow | 121552 | Russia |
| Investigational Site Number 643904 | Moscow | 129090 | Russia |
| Investigational Site Number 643911 | Orenburg | 450000 | Russia |
| Investigational Site Number 643921 | Ryazan | 390026 | Russia |
| Investigational Site Number 643925 | Saint Petersburg | 197110 | Russia |
| Investigational Site Number 643922 | Saint Petersburg | 198205 | Russia |
| Investigational Site Number 643914 | Saint Petersburg | 199106 | Russia |
| Investigational Site Number 643929 | Saratov | 410028 | Russia |
| Investigational Site Number 710917 | Alberton | 1450 | South Africa |
| Investigational Site Number 710909 | Bloemfontein | 9301 | South Africa |
| Investigational Site Number 710914 | Bloemfontein | 9301 | South Africa |
| Investigational Site Number 710905 | Cape Town | 7500 | South Africa |
| Investigational Site Number 710904 | Cape Town | 7925 | South Africa |
| Investigational Site Number 710918 | Middelburg | 1055 | South Africa |
| Investigational Site Number 710913 | Pretoria | 0002 | South Africa |
| Investigational Site Number 710915 | Somerset West | 7130 | South Africa |
| Investigational Site Number 410908 | Anyang-si | 431-070 | South Korea |
| Investigational Site Number 410920 | Busan | 602-715 | South Korea |
| Investigational Site Number 410926 | Daegu | 700-712 | South Korea |
| Investigational Site Number 410923 | Gwangju | 501-757 | South Korea |
| Investigational Site Number 410909 | Seoul | 110-744 | South Korea |
| Investigational Site Number 410922 | Seoul | 120-752 | South Korea |
| Investigational Site Number 410921 | Seoul | 135-710 | South Korea |
| Investigational Site Number 410905 | Seoul | 135-720 | South Korea |
| Investigational Site Number 410901 | Seoul | 137-701 | South Korea |
| Investigational Site Number 410914 | Seoul | 138-736 | South Korea |
| Investigational Site Number 410924 | Seoul | 156-707 | South Korea |
| Investigational Site Number 410915 | Suwon | 443-721 | South Korea |
| Investigational Site Number 410913 | Uijeongbu-si | 480-717 | South Korea |
| Investigational Site Number 410927 | Wŏnju | 220-701 | South Korea |
| Investigational Site Number 804905 | Kiev | 02091 | Ukraine |
| Investigational Site Number 804902 | Uzhhorod | 88009 | Ukraine |
| Result |
| Cannon CP, Cariou B, Blom D, McKenney JM, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM; ODYSSEY COMBO II Investigators. Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial. Eur Heart J. 2015 May 14;36(19):1186-94. doi: 10.1093/eurheartj/ehv028. Epub 2015 Feb 16. |
| 34298554 | Derived | Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10. |
| 30183102 | Derived | Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9. |
| 27777279 | Derived | Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24. |
| FG001 |
| Ezetimibe 10 mg |
Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Alirocumab 75 /up to 150 mg Q2W | Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8. |
| BG001 | Ezetimibe 10 mg | Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Calculated LDL-C in mg/dL | Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Calculated LDL-C in mmol/L | Mean | Standard Deviation | mmol/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis | 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). | ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis | 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). | Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | 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. | ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis | 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). | mITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis | 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. | 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). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis | 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). | Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis | 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. | 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). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis | 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). | 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). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline up to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis | 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. | 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). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis | 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. | Apo-B ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis | 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. | Non-HDL-C ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Total-C at Week 12 - ITT Analysis | 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. | Total-C ITT population | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis | Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model. | ITT population. | Posted | Number | percentage of participants | Up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis | Adjusted percentages at Week 24 from multiple imputation approach 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). | mITT population. | Posted | Number | percentage of participants | Up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model. | ITT population. | Posted | Mean | Standard Error | percent change | From baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis | 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. | Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis | Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis | 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. | Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population). | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis | 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. | HDL-C ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis | Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis | 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. | Apo A-1 ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 52 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). | mITT population. | Posted | Least Squares Mean | Standard Error | Percent change | From Baseline to Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis | Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment. | ITT population. | Posted | Least Squares Mean | Standard Error | Percent change | From Baseline to Week 104 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first). | mITT population. | Posted | Least Squares Mean | Standard Error | Percent change | From Baseline to Week 104 |
|
|
All Adverse Events (AE) were collected from signature of the informed consent form up to final visit (Week 112) in the study regardless of seriousness or relationship to study drugs.
Reported AEs are treatment emergent that is AEs that developed/worsened during 'the treatment emergent period' (from the first dose of double-blind study drug administration [capsule or injection, whichever came first] up the day of the last double blind injection + 70 days).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alirocumab 75/Up to 150 mg Q2W | Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks). | 124 | 479 | 185 | 479 | ||
| EG001 | Ezetimibe 10 mg | Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks). | 60 | 241 | 90 | 241 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Cellulitis of male external genital organ | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Scrotal abscess | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Myringitis bullous | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Oestrogen receptor positive breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Non-small cell lung cancer stage IIIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDra 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cerebrosclerosis | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ophthalmoplegia | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cupulolithiasis | Ear and labyrinth disorders | MedDra 18.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Silent myocardial infarction | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Defect conduction intraventricular | Cardiac disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Spinal instability | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDra 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDra 18.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDra 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 18.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 18.0 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDra 18.0 | Systematic Assessment |
|
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).
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571059 | alirocumab |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|