Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
23. juni 2016 opdateret af: Sanofi
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
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:
- To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
- To evaluate the effect of alirocumab on other lipid parameters
- To evaluate the safety and tolerability of alirocumab
Studieoversigt
Status
Status
Afsluttet
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
720
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Brampton, Canada, L6T 3J1
- Investigational Site Number 124902
-
Mirabel, Canada, J7J 2K8
- Investigational Site Number 124914
-
Montreal, Canada, H1T 3Y7
- Investigational Site Number 124903
-
Toronto, Canada, M9V 4B4
- Investigational Site Number 124918
-
-
-
-
-
Esbjerg, Danmark, 6700
- Investigational Site Number 208913
-
Glostrup, Danmark, 2600
- Investigational Site Number 208914
-
Hellerup, Danmark, 2900
- Investigational Site Number 208905
-
Herlev, Danmark, 2730
- Investigational Site Number 208911
-
Hvidovre, Danmark, 2650
- Investigational Site Number 208907
-
København S, Danmark, 2300
- Investigational Site Number 208901
-
Køge, Danmark, 4600
- Investigational Site Number 208906
-
Roskilde, Danmark, 4000
- Investigational Site Number 208908
-
Silkeborg, Danmark, 8600
- Investigational Site Number 208903
-
-
-
-
-
Barnaul, Den Russiske Føderation, 656055
- Investigational Site Number 643906
-
Kemerovo, Den Russiske Føderation, 650002
- Investigational Site Number 643903
-
Moscow, Den Russiske Føderation, 111539
- Investigational Site Number 643927
-
Moscow, Den Russiske Føderation, 111539
- Investigational Site Number 643928
-
Moscow, Den Russiske Føderation, 115404
- Investigational Site Number 643931
-
Moscow, Den Russiske Føderation, 119048
- Investigational Site Number 643924
-
Moscow, Den Russiske Føderation, 121374
- Investigational Site Number 643932
-
Moscow, Den Russiske Føderation, 121552
- Investigational Site Number 643908
-
Moscow, Den Russiske Føderation, 129090
- Investigational Site Number 643904
-
Orenburg, Den Russiske Føderation, 450000
- Investigational Site Number 643911
-
Ryazan, Den Russiske Føderation, 390026
- Investigational Site Number 643921
-
Saint-Petersburg, Den Russiske Føderation, 197110
- Investigational Site Number 643925
-
Saint-Petersburg, Den Russiske Føderation, 198205
- Investigational Site Number 643922
-
Saratov, Den Russiske Føderation, 410028
- Investigational Site Number 643929
-
St-Petersburg, Den Russiske Føderation, 199106
- Investigational Site Number 643914
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35209
- Investigational Site Number 840980
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85032
- Investigational Site Number 840918
-
Tucson, Arizona, Forenede Stater
- Investigational Site Number 840925
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- Investigational Site Number 840959
-
Beverly Hills, California, Forenede Stater, 90211
- Investigational Site Number 840301
-
Chino, California, Forenede Stater, 91710
- Investigational Site Number 840933
-
Lincoln, California, Forenede Stater, 95648
- Investigational Site Number 840991
-
Los Angeles, California, Forenede Stater, 90057
- Investigational Site Number 840979
-
Palm Springs, California, Forenede Stater, 92262
- Investigational Site Number 840952
-
Thousand Oaks, California, Forenede Stater, 91360
- Investigational Site Number 840930
-
Vista, California, Forenede Stater, 92083
- Investigational Site Number 840921
-
-
Florida
-
Boynton Beach, Florida, Forenede Stater, 33472
- Investigational Site Number 840962
-
Bradenton, Florida, Forenede Stater, 34203
- Investigational Site Number 840987
-
Clearwater, Florida, Forenede Stater, 33756
- Investigational Site Number 840302
-
Jacksonville, Florida, Forenede Stater, 32223
- Investigational Site Number 840935
-
Miami, Florida, Forenede Stater, 33126
- Investigational Site Number 840903
-
Miami, Florida, Forenede Stater
- Investigational Site Number 840920
-
Ocala, Florida, Forenede Stater, 34471
- Investigational Site Number 840943
-
Oveido, Florida, Forenede Stater, 32765
- Investigational Site Number 840981
-
Port Orange, Florida, Forenede Stater, 32127
- Investigational Site Number 840961
-
Sarasota, Florida, Forenede Stater, 34239
- Investigational Site Number 840303
-
St. Petersburg, Florida, Forenede Stater
- Investigational Site Number 840986
-
St. Petersburg, Florida, Forenede Stater
- Investigational Site Number 840988
-
-
Idaho
-
Meridian, Idaho, Forenede Stater, 83646
- Investigational Site Number 840995
-
-
Indiana
-
Evansville, Indiana, Forenede Stater, 47714
- Investigational Site Number 840902
-
-
Kansas
-
Topeka, Kansas, Forenede Stater, 66606
- Investigational Site Number 840960
-
-
Maryland
-
Oxon Hill, Maryland, Forenede Stater, 20745
- Investigational Site Number 840940
-
-
Massachusetts
-
Fall River, Massachusetts, Forenede Stater, 02720
- Investigational Site Number 840966
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64114
- Investigational Site Number 840917
-
St. Louis, Missouri, Forenede Stater, 63131
- Investigational Site Number 840998
-
-
Montana
-
Butte, Montana, Forenede Stater, 59701
- Investigational Site Number 840946
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68510
- Investigational Site Number 840914
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87106
- Investigational Site Number 840949
-
-
New York
-
New Windsor, New York, Forenede Stater, 12553
- Investigational Site Number 840974
-
-
North Carolina
-
Greenville, North Carolina, Forenede Stater, 27834
- Investigational Site Number 840955
-
Lexington, North Carolina, Forenede Stater, 27292
- Investigational Site Number 840938
-
Smithfield, North Carolina, Forenede Stater, 27577
- Investigational Site Number 840976
-
Winston-Salem, North Carolina, Forenede Stater, 27103
- Investigational Site Number 840985
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- Investigational Site Number 840963
-
Lyndhust, Ohio, Forenede Stater, 44124
- Investigational Site Number 840970
-
Marion, Ohio, Forenede Stater, 43302
- Investigational Site Number 840906
-
Marion, Ohio, Forenede Stater, 43302
- Investigational Site Number 840997
-
Perrysburg, Ohio, Forenede Stater, 43551
- Investigational Site Number 840964
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29412
- Investigational Site Number 840913
-
Greer, South Carolina, Forenede Stater, 29651
- Investigational Site Number 840912
-
Summerville, South Carolina, Forenede Stater, 29485
- Investigational Site Number 840992
-
-
Tennessee
-
Bristol, Tennessee, Forenede Stater, 37620
- Investigational Site Number 840932
-
Nashville, Tennessee, Forenede Stater, 37205
- Investigational Site Number 840944
-
-
Texas
-
Fort Worth, Texas, Forenede Stater, 76104
- Investigational Site Number 840994
-
Houston, Texas, Forenede Stater, 77070
- Investigational Site Number 840973
-
Houston, Texas, Forenede Stater, 77074
- Investigational Site Number 840939
-
Sugar Land, Texas, Forenede Stater, 77479
- Investigational Site Number 840945
-
Tomball, Texas, Forenede Stater, 77375
- Investigational Site Number 840971
-
-
Utah
-
Orem, Utah, Forenede Stater, 84058
- Investigational Site Number 840982
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater, 23502
- Investigational Site Number 840931
-
Richmond, Virginia, Forenede Stater, 23227
- Investigational Site Number 840984
-
-
Washington
-
Renton, Washington, Forenede Stater, 98055
- Investigational Site Number 840928
-
Spokane, Washington, Forenede Stater, 99204
- Investigational Site Number 840990
-
-
-
-
-
Dijon, Frankrig, 21079
- Investigational Site Number 250906
-
Montpellier Cedex 5, Frankrig, 34295
- Investigational Site Number 250907
-
Nantes, Frankrig, 44093
- Investigational Site Number 250903
-
Nimes, Frankrig, 30900
- Investigational Site Number 250905
-
-
-
-
-
Holon, Israel, 58100
- Investigational Site Number 376908
-
Kfar Saba, Israel, 44281
- Investigational Site Number 376903
-
Ofakim, Israel, 80300
- Investigational Site Number 376906
-
Petach Tikva, Israel
- Investigational Site Number 376902
-
Rehovot, Israel, 76100
- Investigational Site Number 376904
-
Safed, Israel, 13100
- Investigational Site Number 376907
-
Tel Aviv, Israel, 64239
- Investigational Site Number 376901
-
-
-
-
-
Anyang-Si, Korea, Republikken, 431-070
- Investigational Site Number 410908
-
Busan, Korea, Republikken, 602-715
- Investigational Site Number 410920
-
Daegu, Korea, Republikken, 700-712
- Investigational Site Number 410926
-
Gwangju, Korea, Republikken, 501-757
- Investigational Site Number 410923
-
Seoul, Korea, Republikken, 110-744
- Investigational Site Number 410909
-
Seoul, Korea, Republikken, 120-752
- Investigational Site Number 410922
-
Seoul, Korea, Republikken, 135-710
- Investigational Site Number 410921
-
Seoul, Korea, Republikken, 135-720
- Investigational Site Number 410905
-
Seoul, Korea, Republikken, 137-701
- Investigational Site Number 410901
-
Seoul, Korea, Republikken, 138-736
- Investigational Site Number 410914
-
Seoul, Korea, Republikken, 156-707
- Investigational Site Number 410924
-
Suwon, Korea, Republikken, 443-721
- Investigational Site Number 410915
-
Uijeongbu, Korea, Republikken, 480-717
- Investigational Site Number 410913
-
Wonju, Korea, Republikken, 220-701
- Investigational Site Number 410927
-
-
-
-
-
Alberton, Sydafrika, 1450
- Investigational Site Number 710917
-
Bloemfontein, Sydafrika, 9301
- Investigational Site Number 710909
-
Bloemfontein, Sydafrika, 9301
- Investigational Site Number 710914
-
Cape Town, Sydafrika, 7500
- Investigational Site Number 710905
-
Cape Town, Sydafrika, 7925
- Investigational Site Number 710904
-
Middelburg, Sydafrika, 1055
- Investigational Site Number 710918
-
Pretoria, Sydafrika, 0002
- Investigational Site Number 710913
-
Somerset West, Sydafrika, 7130
- Investigational Site Number 710915
-
-
-
-
-
Kiev, Ukraine, 02091
- Investigational Site Number 804905
-
Uzhhorod, Ukraine, 88009
- Investigational Site Number 804902
-
-
-
-
-
Budapest, Ungarn, 1036
- Investigational Site Number 348908
-
Budapest, Ungarn, 1134
- Investigational Site Number 348901
-
Budapest, Ungarn, 1134
- Investigational Site Number 348903
-
Debrecen, Ungarn, 4032
- Investigational Site Number 348905
-
Szekesfehervar, Ungarn, 8000
- Investigational Site Number 348906
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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:
- Age < 18 or legal age of adulthood, whichever was greater
- Participants without established CHD or CHD risk equivalents
- LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
- LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease
- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Alirocumab 75 /up to 150 mg Q2W
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.
|
1 mL subkutan injektion i maven, låret eller det ydre område af overarmen ved selvinjektion eller af en anden udpeget person, der bruger autoinjektoren.
Andre navne:
One capsule once daily orally at approximately the same time of the day with or without food.
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
|
|
Aktiv komparator: Ezetimibe 10 mg
Ezetimibe 10 mg capsule daily and subcutaneous placebo for alirocumab Q2W added to stable LMT for 104 weeks.
|
Én overindkapslet tablet oralt én gang dagligt på omtrent samme tidspunkt på dagen med eller uden mad.
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data.
All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).
|
From Baseline to Week 52
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentvis ændring fra baseline i ikke-højdensitetslipoproteinkolesterol (ikke-HDL-C) i uge 24 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 24 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til- eller slukket for behandling.
|
Fra baseline til uge 52
|
|
Procentvis ændring fra baseline i totalt kolesterol (Total-C) i uge 24 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 24 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til- eller slukket for behandling.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i ikke-HDL-C i uge 12 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 12 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til eller uden behandling.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i Total-C i uge 12 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 12 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til eller uden behandling.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i HDL-C i uge 24 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 24 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til- eller slukket for behandling.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i HDL-C i uge 12 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 12 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til eller uden behandling.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i Lipoprotein(a) i uge 24 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede gennemsnit og standardfejl i uge 24 blev opnået fra multiple imputationstilgang efterfulgt af robust regressionsmodel til håndtering af manglende data.
Alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til- eller uden behandling blev inkluderet i imputationsmodellen.
|
Fra baseline til uge 52
|
|
Procent ændring fra baseline i Apo A-1 i uge 12 - ITT-analyse
Tidsramme: Fra baseline til uge 52
|
Justerede LS-middelværdier og standardfejl i uge 12 fra MMRM-modellen inklusive alle tilgængelige post-baseline-data fra uge 4 til uge 52 uanset status til- eller slukket for behandling.
|
Fra baseline til uge 52
|
|
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
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
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
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 Calculated LDL--C at Week 24 - On--Treatment Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Tidsramme: From Baseline up to Week 52
|
Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).
|
From Baseline up to Week 52
|
|
Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
|
From Baseline to Week 52
|
|
Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
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
Tidsramme: Up to Week 52
|
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
Tidsramme: Up to Week 52
|
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 12 - ITT Analysis
Tidsramme: From Baseline to Week 52
|
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
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
Tidsramme: From Baseline to Week 52
|
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
|
|
Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis
Tidsramme: From Baseline to Week 104
|
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
Tidsramme: From Baseline to Week 104
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
Studiestart
1. august 2012
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
1. maj 2014
Studieafslutning (Faktiske)
Studieafslutning
1. juli 2015
Datoer for studieregistrering
Først indsendt
Først indsendt
16. juli 2012
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
16. juli 2012
Først opslået (Skøn)
Først opslået
18. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
4. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. juni 2016
Sidst verificeret
Sidst verificeret
1. juni 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Lipidmetabolismeforstyrrelser
- Hyperlipidæmi
- Dyslipidæmi
- Hyperkolesterolæmi
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter
- Immunologiske faktorer
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Antistoffer, monoklonale
- Ezetimibe
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EFC11569
- U1111-1121-4315 (Anden identifikator: UTN)
- 2011-004130-34 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .