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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1121-4275 | Other Identifier | UTN | |
| 2011-005109-56 | EudraCT Number |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
Secondary Objectives:
The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks. |
|
| Alirocumab 75 mg/Up to 150 mg Q2W | Experimental | Alirocumab 75 mg Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alirocumab | Drug | Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). |
| 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 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) (on-treatment analysis). | 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). | From Baseline to Week 52 |
| Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis |
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 840417 | Bell Gardens | California | 90201 | United States | ||
| Investigational Site Number 840429 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24842558 | Background | Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z. | |
| 26330422 |
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Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, intensity of statin treatment & geographic region. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in 1:2 (placebo:alirocumab) after confirmation of selection criteria. 486 participants were randomized.
The study was conducted at 89 centers in 14 countries. A total of 597 participants were screened between July 2012 and April 2013, 111 of whom were screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks. |
| FG001 | Alirocumab 75 mg/Up to 150 mg Q2W |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo (for alirocumab) | Drug | Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). |
|
| Lipid Modifying Therapy (LMT) | Drug | Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated. |
|
| Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis |
Adjusted LS means and standard errors at Week 12 from 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). | 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). | 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). | From Baseline 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 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 Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis | Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). 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 Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 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. | Up 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 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | 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 model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection. | Up to Week 52 |
| Percent Change From Baseline in Lipoprotein (a) 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 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 |
Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment. |
| From Baseline to Week 78 |
| Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection). | From Baseline to Week 78 |
| Long Beach |
| California |
| 90801 |
| United States |
| Investigational Site Number 840419 | Los Angeles | California | 90048 | United States |
| Investigational Site Number 840421 | Mission Viejo | California | 92691 | United States |
| Investigational Site Number 840412 | Newport Beach | California | 92660 | United States |
| Investigational Site Number 840428 | Newport Beach | California | United States |
| Investigational Site Number 840461 | Northridge | California | 91324 | United States |
| Investigational Site Number 840452 | Washington D.C. | District of Columbia | 20037 | United States |
| Investigational Site Number 840456 | Miami | Florida | 33165 | United States |
| Investigational Site Number 840418 | Ponte Vedra | Florida | 32081 | United States |
| Investigational Site Number 840455 | Evanston | Illinois | 60201 | United States |
| Investigational Site Number 840415 | Kansas City | Kansas | 66160-7321 | United States |
| Investigational Site Number 840425 | Auburn | Maine | 04210 | United States |
| Investigational Site Number 840411 | Boston | Massachusetts | 02114 | United States |
| Investigational Site Number 840409 | St Louis | Missouri | 63110 | United States |
| Investigational Site Number 840407 | Morristown | New Jersey | 07962 | United States |
| Investigational Site Number 840408 | New York | New York | 10032 | United States |
| Investigational Site Number 840401 | Charlotte | North Carolina | 28207 | United States |
| Investigational Site Number 840410 | Durham | North Carolina | 27710 | United States |
| Investigational Site Number 840430 | Cincinnati | Ohio | 45219 | United States |
| Investigational Site Number 840424 | Portland | Oregon | 97201-3098 | United States |
| Investigational Site Number 840404 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number 840426 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number 840406 | Nashville | Tennessee | 37232 | United States |
| Investigational Site Number 840460 | Dallas | Texas | 75216 | United States |
| Investigational Site Number 840422 | Bountiful | Utah | 84010 | United States |
| Investigational Site Number 040403 | Graz | 8036 | Austria |
| Investigational Site Number 040402 | Vienna | 1130 | Austria |
| Investigational Site Number 040405 | Vienna | Austria |
| Investigational Site Number 124404 | Chicoutimi | G7H 5H6 | Canada |
| Investigational Site Number 124401 | Montreal | H2W 1R7 | Canada |
| Investigational Site Number 124403 | Québec | G1V 4M6 | Canada |
| Investigational Site Number 124406 | Sherbrooke | J1H 5N4 | Canada |
| Investigational Site Number 124407 | Toronto | M5C 2T2 | Canada |
| Investigational Site Number 203401 | Prague | 140 00 | Czechia |
| Investigational Site Number 203403 | Prague | 180 00 | Czechia |
| Investigational Site Number 203405 | Uherské Hradiště | Czechia |
| Investigational Site Number 203402 | Zlín | 760 00 | Czechia |
| Investigational Site Number 208401 | Copenhagen | Denmark |
| Investigational Site Number 208403 | Esbjerg | 6700 | Denmark |
| Investigational Site Number 250403 | Dijon | 21000 | France |
| Investigational Site Number 250401 | Paris | 75651 | France |
| Investigational Site Number 250402 | Saint-Herblain | 44093 | France |
| Investigational Site Number 376402 | Holon | 76100 | Israel |
| Investigational Site Number 376405 | Jerusalem | Israel |
| Investigational Site Number 376404 | Safed | 13100 | Israel |
| Investigational Site Number 376401 | Tel Litwinsky | 52621 | Israel |
| Investigational Site Number 528406 | Amsterdam | 1105 AZ | Netherlands |
| Investigational Site Number 528410 | Amsterdam | Netherlands |
| Investigational Site Number 528408 | Den Helder | 1782 GZ | Netherlands |
| Investigational Site Number 528402 | Groningen | 9728 NT | Netherlands |
| Investigational Site Number 528411 | Leiden | 2333 ZA | Netherlands |
| Investigational Site Number 528416 | Maastricht | 6229 HX | Netherlands |
| Investigational Site Number 528409 | Nieuwegein | 3435 CM | Netherlands |
| Investigational Site Number 528412 | Sliedrecht | Netherlands |
| Investigational Site Number 578401 | Bodø | 8092 | Norway |
| Investigational Site Number 643402 | Arkhangelsk | 163000 | Russia |
| Investigational Site Number 643407 | Kazan' | 420012 | Russia |
| Investigational Site Number 643409 | Moscow | 111539 | Russia |
| Investigational Site Number 643413 | Moscow | 121552 | Russia |
| Investigational Site Number 643401 | Moscow | 129301 | Russia |
| Investigational Site Number 643412 | Novisibirsk | Russia |
| Investigational Site Number 643408 | Saint Petersburg | 193079 | Russia |
| Investigational Site Number 643406 | Saint Petersburg | 194291 | Russia |
| Investigational Site Number 643404 | Saint Petersburg | 197341 | Russia |
| Investigational Site Number 643410 | Yaroslavl | 150062 | Russia |
| Investigational Site Number 710401 | Bloemfontein | South Africa |
| Investigational Site Number 710405 | Bloemfontein | South Africa |
| Investigational Site Number 710406 | Cap Town | 7530 | South Africa |
| Investigational Site Number 710402 | Cape Town | 7708 | South Africa |
| Investigational Site Number 710407 | Parktown | 2193 | South Africa |
| Investigational Site Number 710403 | Parow | 7500 | South Africa |
| Investigational Site Number 710408 | Pretoria | South Africa |
| Investigational Site Number 710404 | Rondebosch | South Africa |
| Investigational Site Number 710409 | Somerset West | 7130 | South Africa |
| Investigational Site Number 724403 | A Coruña | 15006 | Spain |
| Investigational Site Number 724408 | Barcelona | 08036 | Spain |
| Investigational Site Number 724406 | Córdoba | 14004 | Spain |
| Investigational Site Number 724407 | L'Hospitalet de Llobregat | 08907 | Spain |
| Investigational Site Number 724409 | Madrid | 28029 | Spain |
| Investigational Site Number 724401 | Madrid | 28040 | Spain |
| Investigational Site Number 724405 | Madrid | 28040 | Spain |
| Investigational Site Number 724404 | Reus | 43201 | Spain |
| Investigational Site Number 724402 | Zaragoza | 50009 | Spain |
| Investigational Site Number 752404 | Gothenburg | 41345 | Sweden |
| Investigational Site Number 752401 | Stockholm | 111 35 | Sweden |
| Investigational Site Number 826402 | London | United Kingdom |
| Investigational Site Number 826403 | London | United Kingdom |
| Investigational Site Number 826408 | London | United Kingdom |
| Investigational Site Number 826409 | London | United Kingdom |
| Investigational Site Number 826405 | Manchester | M23 9LT | United Kingdom |
| Result |
| Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1. |
| 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. |
| 28964736 | Derived | Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. |
| 28391886 | Derived | Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28. |
| 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. |
Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks. |
| BG001 | Alirocumab 75 mg/Up to 150 mg Q2W | Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Calculated LDL-C in mg/dL | Calculated LDL-C 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 |
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| 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 |
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| Secondary | Percent Change From Baseline in Calculated LDL-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) (on-treatment analysis). | Modified ITT (mITT) population: 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 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis | Adjusted LS means and standard errors at Week 12 from 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 |
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| 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). | mITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| 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 |
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| 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). | 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 |
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| 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 |
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| 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). | 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 to Week 52 |
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| 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 |
|
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| 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 |
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| 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 |
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| 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 |
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| Secondary | Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis | Adjusted LS means and standard errors at Week 52 from 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 |
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| Secondary | Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis | Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). 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 Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 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. | mITT population. | Posted | Number | percentage of participants | Up to Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment. | ITT population. | Posted | Number | percentage of participants | Up to Week 52 |
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| 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 model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection. | mITT population. | Posted | Number | percentage of participants | Up to Week 52 |
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| Secondary | Percent Change From Baseline in Lipoprotein (a) 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 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
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| 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 |
|
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| 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 |
|
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| 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 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
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| 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 |
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| 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 |
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| 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). | mITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 52 |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis | Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment. | ITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 78 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis | Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection). | mITT population. | Posted | Least Squares Mean | Standard Error | percent change | From Baseline to Week 78 |
|
|
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit in the study regardless of seriousness or relationship to study drug.
Reported adverse events are treatment-emergent that is AEs that developed/worsened during the 'treatment-emergent period' (from the first double-blind injection up to the day of the last injection + 70 days or up to first intake in the extension study, whichever came first).
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 | Placebo | Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks). | 22 | 163 | 70 | 163 | ||
| EG001 | Alirocumab 75/Up to 150 mg Q2W | Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks). | 44 | 322 | 142 | 322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Acinic cell carcinoma of salivary gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal artery embolism | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Retinal degeneration | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Trousseau's syndrome | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Colonic pseudo-obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA 17.1 | Systematic Assessment |
| |
| Miscarriage of partner | Social circumstances | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 17.1 | 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 |
Not provided
Not provided
Not provided
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