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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 oppdatert av: 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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

720

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
      • 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
  • Danmark
      • 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
  • Den russiske føderasjonen
      • Barnaul, Den russiske føderasjonen, 656055
        • Investigational Site Number 643906
      • Kemerovo, Den russiske føderasjonen, 650002
        • Investigational Site Number 643903
      • Moscow, Den russiske føderasjonen, 111539
        • Investigational Site Number 643927
      • Moscow, Den russiske føderasjonen, 111539
        • Investigational Site Number 643928
      • Moscow, Den russiske føderasjonen, 115404
        • Investigational Site Number 643931
      • Moscow, Den russiske føderasjonen, 119048
        • Investigational Site Number 643924
      • Moscow, Den russiske føderasjonen, 121374
        • Investigational Site Number 643932
      • Moscow, Den russiske føderasjonen, 121552
        • Investigational Site Number 643908
      • Moscow, Den russiske føderasjonen, 129090
        • Investigational Site Number 643904
      • Orenburg, Den russiske føderasjonen, 450000
        • Investigational Site Number 643911
      • Ryazan, Den russiske føderasjonen, 390026
        • Investigational Site Number 643921
      • Saint-Petersburg, Den russiske føderasjonen, 197110
        • Investigational Site Number 643925
      • Saint-Petersburg, Den russiske føderasjonen, 198205
        • Investigational Site Number 643922
      • Saratov, Den russiske føderasjonen, 410028
        • Investigational Site Number 643929
      • St-Petersburg, Den russiske føderasjonen, 199106
        • Investigational Site Number 643914
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35209
        • Investigational Site Number 840980
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Investigational Site Number 840918
      • Tucson, Arizona, Forente stater
        • Investigational Site Number 840925
    • California
      • Anaheim, California, Forente stater, 92801
        • Investigational Site Number 840959
      • Beverly Hills, California, Forente stater, 90211
        • Investigational Site Number 840301
      • Chino, California, Forente stater, 91710
        • Investigational Site Number 840933
      • Lincoln, California, Forente stater, 95648
        • Investigational Site Number 840991
      • Los Angeles, California, Forente stater, 90057
        • Investigational Site Number 840979
      • Palm Springs, California, Forente stater, 92262
        • Investigational Site Number 840952
      • Thousand Oaks, California, Forente stater, 91360
        • Investigational Site Number 840930
      • Vista, California, Forente stater, 92083
        • Investigational Site Number 840921
    • Florida
      • Boynton Beach, Florida, Forente stater, 33472
        • Investigational Site Number 840962
      • Bradenton, Florida, Forente stater, 34203
        • Investigational Site Number 840987
      • Clearwater, Florida, Forente stater, 33756
        • Investigational Site Number 840302
      • Jacksonville, Florida, Forente stater, 32223
        • Investigational Site Number 840935
      • Miami, Florida, Forente stater, 33126
        • Investigational Site Number 840903
      • Miami, Florida, Forente stater
        • Investigational Site Number 840920
      • Ocala, Florida, Forente stater, 34471
        • Investigational Site Number 840943
      • Oveido, Florida, Forente stater, 32765
        • Investigational Site Number 840981
      • Port Orange, Florida, Forente stater, 32127
        • Investigational Site Number 840961
      • Sarasota, Florida, Forente stater, 34239
        • Investigational Site Number 840303
      • St. Petersburg, Florida, Forente stater
        • Investigational Site Number 840986
      • St. Petersburg, Florida, Forente stater
        • Investigational Site Number 840988
    • Idaho
      • Meridian, Idaho, Forente stater, 83646
        • Investigational Site Number 840995
    • Indiana
      • Evansville, Indiana, Forente stater, 47714
        • Investigational Site Number 840902
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • Investigational Site Number 840960
    • Maryland
      • Oxon Hill, Maryland, Forente stater, 20745
        • Investigational Site Number 840940
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02720
        • Investigational Site Number 840966
    • Missouri
      • Kansas City, Missouri, Forente stater, 64114
        • Investigational Site Number 840917
      • St. Louis, Missouri, Forente stater, 63131
        • Investigational Site Number 840998
    • Montana
      • Butte, Montana, Forente stater, 59701
        • Investigational Site Number 840946
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68510
        • Investigational Site Number 840914
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • Investigational Site Number 840949
    • New York
      • New Windsor, New York, Forente stater, 12553
        • Investigational Site Number 840974
    • North Carolina
      • Greenville, North Carolina, Forente stater, 27834
        • Investigational Site Number 840955
      • Lexington, North Carolina, Forente stater, 27292
        • Investigational Site Number 840938
      • Smithfield, North Carolina, Forente stater, 27577
        • Investigational Site Number 840976
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Investigational Site Number 840985
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45219
        • Investigational Site Number 840963
      • Lyndhust, Ohio, Forente stater, 44124
        • Investigational Site Number 840970
      • Marion, Ohio, Forente stater, 43302
        • Investigational Site Number 840906
      • Marion, Ohio, Forente stater, 43302
        • Investigational Site Number 840997
      • Perrysburg, Ohio, Forente stater, 43551
        • Investigational Site Number 840964
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29412
        • Investigational Site Number 840913
      • Greer, South Carolina, Forente stater, 29651
        • Investigational Site Number 840912
      • Summerville, South Carolina, Forente stater, 29485
        • Investigational Site Number 840992
    • Tennessee
      • Bristol, Tennessee, Forente stater, 37620
        • Investigational Site Number 840932
      • Nashville, Tennessee, Forente stater, 37205
        • Investigational Site Number 840944
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
        • Investigational Site Number 840994
      • Houston, Texas, Forente stater, 77070
        • Investigational Site Number 840973
      • Houston, Texas, Forente stater, 77074
        • Investigational Site Number 840939
      • Sugar Land, Texas, Forente stater, 77479
        • Investigational Site Number 840945
      • Tomball, Texas, Forente stater, 77375
        • Investigational Site Number 840971
    • Utah
      • Orem, Utah, Forente stater, 84058
        • Investigational Site Number 840982
    • Virginia
      • Norfolk, Virginia, Forente stater, 23502
        • Investigational Site Number 840931
      • Richmond, Virginia, Forente stater, 23227
        • Investigational Site Number 840984
    • Washington
      • Renton, Washington, Forente stater, 98055
        • Investigational Site Number 840928
      • Spokane, Washington, Forente stater, 99204
        • Investigational Site Number 840990
  • Frankrike
      • Dijon, Frankrike, 21079
        • Investigational Site Number 250906
      • Montpellier Cedex 5, Frankrike, 34295
        • Investigational Site Number 250907
      • Nantes, Frankrike, 44093
        • Investigational Site Number 250903
      • Nimes, Frankrike, 30900
        • Investigational Site Number 250905
  • Israel
      • 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
  • Korea, Republikken
      • 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
  • Sør-Afrika
      • Alberton, Sør-Afrika, 1450
        • Investigational Site Number 710917
      • Bloemfontein, Sør-Afrika, 9301
        • Investigational Site Number 710909
      • Bloemfontein, Sør-Afrika, 9301
        • Investigational Site Number 710914
      • Cape Town, Sør-Afrika, 7500
        • Investigational Site Number 710905
      • Cape Town, Sør-Afrika, 7925
        • Investigational Site Number 710904
      • Middelburg, Sør-Afrika, 1055
        • Investigational Site Number 710918
      • Pretoria, Sør-Afrika, 0002
        • Investigational Site Number 710913
      • Somerset West, Sør-Afrika, 7130
        • Investigational Site Number 710915
  • Ukraina
      • Kiev, Ukraina, 02091
        • Investigational Site Number 804905
      • Uzhhorod, Ukraina, 88009
        • Investigational Site Number 804902
  • Ungarn
      • 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Alirocumab
1 ml subkutan injeksjon i magen, låret eller det ytre området av overarmen ved selvinjeksjon eller av en annen utpekt person som bruker autoinjektoren.
Andre navn:
  • Praluent
  • REGN727/SAR236553
Legemiddel: Placebo (for ezetimibe)
One capsule once daily orally at approximately the same time of the day with or without food.
Legemiddel: Lipid Modifying Therapy (LMT)
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.
Legemiddel: Ezetimibe
Én overinnkapslet tablett oralt én gang daglig til omtrent samme tid på dagen med eller uten mat.
Legemiddel: Lipid Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
Legemiddel: Placebo (for alirocumab)
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentvis endring fra baseline i ikke-høydensitetslipoproteinkolesterol (ikke-HDL-C) ved uke 24 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 24 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i totalt kolesterol (total-C) ved uke 24 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 24 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i ikke-HDL-C ved uke 12 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 12 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i Total-C ved uke 12 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 12 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i HDL-C ved uke 24 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 24 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i HDL-C ved uke 12 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 12 fra MMRM-modellen inkludert alle tilgjengelige post-baseline data fra uke 4 til uke 52 uavhengig av status på eller av behandling.
Fra baseline til uke 52
Prosentvis endring fra baseline i Lipoprotein(a) ved uke 24 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte gjennomsnitt og standardfeil ved uke 24 ble hentet fra multippel imputering etterfulgt av robust regresjonsmodell for håndtering av manglende data. Alle tilgjengelige post-baseline-data fra uke 4 til uke 52 uavhengig av status på eller utenfor behandling ble inkludert i imputasjonsmodellen.
Fra baseline til uke 52
Prosentvis endring fra baseline i Apo A-1 ved uke 12 - ITT-analyse
Tidsramme: Fra baseline til uke 52
Justerte LS-middelverdier og standardfeil ved uke 12 fra MMRM-modellen inkludert alle tilgjengelige post-baseline-data fra uke 4 til uke 52 uavhengig av status på eller av-behandling.
Fra baseline til uke 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

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Samarbeidspartnere

Regeneron Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2012

Primær fullføring (Faktiske)

1. mai 2014

Studiet fullført (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først innsendt

16. juli 2012

Først innsendt som oppfylte QC-kriteriene

16. juli 2012

Først lagt ut (Anslag)

18. juli 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

4. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2016

Sist bekreftet

1. juni 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EFC11569
  • U1111-1121-4315 (Annen identifikator: UTN)
  • 2011-004130-34 (EudraCT-nummer)

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