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Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood (FIRST)

1. juni 2018 opdateret af: AbbVie (prior sponsor, Abbott)

Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

682

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Arizona
      • Chandler, Arizona, Forenede Stater, 85225
        • Site Reference ID/Investigator# 6747
      • Gilbert, Arizona, Forenede Stater, 85295
        • Site Reference ID/Investigator# 7089
      • Mesa, Arizona, Forenede Stater, 85206
        • Site Reference ID/Investigator# 7097
      • Phoenix, Arizona, Forenede Stater, 85032
        • Site Reference ID/Investigator# 26394
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Site Reference ID/Investigator# 6848
      • Tempe, Arizona, Forenede Stater, 85282
        • Site Reference ID/Investigator# 7059
      • Tempe, Arizona, Forenede Stater, 85282
        • Site Reference ID/Investigator# 7094
      • Tempe, Arizona, Forenede Stater, 85282
        • Site Reference ID/Investigator# 7098
    • California
      • Anaheim, California, Forenede Stater, 92804
        • Site Reference ID/Investigator# 25082
      • Corona, California, Forenede Stater, 92879-3109
        • Site Reference ID/Investigator# 21347
      • Garden Grove, California, Forenede Stater, 92843
        • Site Reference ID/Investigator# 21483
      • Huntington Beach, California, Forenede Stater, 92648
        • Site Reference ID/Investigator# 21351
      • Laguna Hills, California, Forenede Stater, 92653
        • Site Reference ID/Investigator# 21346
      • Long Beach, California, Forenede Stater, 90806
        • Site Reference ID/Investigator# 21341
      • Norwalk, California, Forenede Stater, 90650
        • Site Reference ID/Investigator# 21342
      • Santa Ana, California, Forenede Stater, 92705
        • Site Reference ID/Investigator# 21321
      • Tustin, California, Forenede Stater, 92780
        • Site Reference ID/Investigator# 26242
    • Colorado
      • Arvada, Colorado, Forenede Stater, 80005-3927
        • Site Reference ID/Investigator# 15283
      • Aurora, Colorado, Forenede Stater, 80012
        • Site Reference ID/Investigator# 7085
      • Denver, Colorado, Forenede Stater, 80239
        • Site Reference ID/Investigator# 6749
      • Denver, Colorado, Forenede Stater, 80246
        • Site Reference ID/Investigator# 7077
      • Golden, Colorado, Forenede Stater, 80401
        • Site Reference ID/Investigator# 7092
      • Littleton, Colorado, Forenede Stater, 80122
        • Site Reference ID/Investigator# 7722
      • Littleton, Colorado, Forenede Stater, 80127
        • Site Reference ID/Investigator# 7721
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Site Reference ID/Investigator# 11925
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Site Reference ID/Investigator# 15861
      • Deerfield Beach, Florida, Forenede Stater, 33442
        • Site Reference ID/Investigator# 14422
      • Delray Beach, Florida, Forenede Stater, 33445
        • Site Reference ID/Investigator# 19281
      • Hollywood, Florida, Forenede Stater, 33021
        • Site Reference ID/Investigator# 20881
      • Kissimmee, Florida, Forenede Stater, 34741
        • Site Reference ID/Investigator# 20882
      • Melbourne, Florida, Forenede Stater, 32901
        • Site Reference ID/Investigator# 19321
      • Melbourne, Florida, Forenede Stater, 32901
        • Site Reference ID/Investigator# 21353
      • Melbourne, Florida, Forenede Stater, 32935
        • Site Reference ID/Investigator# 18503
      • Vero Beach, Florida, Forenede Stater, 32960
        • Site Reference ID/Investigator# 18841
      • Vero Beach, Florida, Forenede Stater, 32960
        • Site Reference ID/Investigator# 19961
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Site Reference ID/Investigator# 7166
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Site Reference ID/Investigator# 6744
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Site Reference ID/Investigator# 19301
      • Atlanta, Georgia, Forenede Stater, 30342-1524
        • Site Reference ID/Investigator# 7051
      • Atlanta, Georgia, Forenede Stater, 30342
        • Site Reference ID/Investigator# 7109
      • Dawsonville, Georgia, Forenede Stater, 30534
        • Site Reference ID/Investigator# 7326
      • Decatur, Georgia, Forenede Stater, 30033
        • Site Reference ID/Investigator# 7325
      • Dunwoody, Georgia, Forenede Stater, 30338
        • Site Reference ID/Investigator# 7057
      • Dunwoody, Georgia, Forenede Stater, 30338
        • Site Reference ID/Investigator# 7101
      • Roswell, Georgia, Forenede Stater, 30076
        • Site Reference ID/Investigator# 11324
      • Roswell, Georgia, Forenede Stater, 30076
        • Site Reference ID/Investigator# 6741
      • Suwanee, Georgia, Forenede Stater, 30024
        • Site Reference ID/Investigator# 7103
    • Illinois
      • Addison, Illinois, Forenede Stater, 60101
        • Site Reference ID/Investigator# 10761
      • Aurora, Illinois, Forenede Stater, 60504
        • Site Reference ID/Investigator# 6748
      • Aurora, Illinois, Forenede Stater, 60506
        • Site Reference ID/Investigator# 6742
      • Belleville, Illinois, Forenede Stater, 62220-1986
        • Site Reference ID/Investigator# 7128
      • Chicago, Illinois, Forenede Stater, 60607
        • Site Reference ID/Investigator# 7069
      • Chicago, Illinois, Forenede Stater, 60612-9985
        • Site Reference ID/Investigator# 6849
      • Chicago, Illinois, Forenede Stater, 60612
        • Site Reference ID/Investigator# 6867
      • Chicago, Illinois, Forenede Stater, 60616
        • Site Reference ID/Investigator# 6751
      • Chicago, Illinois, Forenede Stater, 60631
        • Site Reference ID/Investigator# 6847
      • Chicago, Illinois, Forenede Stater, 60654
        • Site Reference ID/Investigator# 7049
      • Gurnee, Illinois, Forenede Stater, 60031
        • Site Reference ID/Investigator# 7093
      • Hazel Crest, Illinois, Forenede Stater, 60429
        • Site Reference ID/Investigator# 6746
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Site Reference ID/Investigator# 6743
      • Naperville, Illinois, Forenede Stater, 60564
        • Site Reference ID/Investigator# 7090
      • Oak Brook, Illinois, Forenede Stater, 60523
        • Site Reference ID/Investigator# 6750
      • Oak Park, Illinois, Forenede Stater, 60304
        • Site Reference ID/Investigator# 6788
      • Vernon Hills, Illinois, Forenede Stater, 60061
        • Site Reference ID/Investigator# 6927
    • Kentucky
      • Erlanger, Kentucky, Forenede Stater, 41018
        • Site Reference ID/Investigator# 7076
    • Minnesota
      • Bloomington, Minnesota, Forenede Stater, 55420
        • Site Reference ID/Investigator# 8103
      • Brooklyn Center, Minnesota, Forenede Stater, 55430
        • Site Reference ID/Investigator# 15121
      • Edina, Minnesota, Forenede Stater, 55435
        • Site Reference ID/Investigator# 7050
      • Edina, Minnesota, Forenede Stater, 55435
        • Site Reference ID/Investigator# 7084
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Site Reference ID/Investigator# 6860
      • Saint Louis, Missouri, Forenede Stater, 63117
        • Site Reference ID/Investigator# 13182
      • Saint Louis, Missouri, Forenede Stater, 63128
        • Site Reference ID/Investigator# 14423
      • Saint Louis, Missouri, Forenede Stater, 63141-6399
        • Site Reference ID/Investigator# 14541
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Site Reference ID/Investigator# 6740
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Site Reference ID/Investigator# 7053
      • Saint Peters, Missouri, Forenede Stater, 63376
        • Site Reference ID/Investigator# 6784
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Site Reference ID/Investigator# 7063
      • Henderson, Nevada, Forenede Stater, 89052
        • Site Reference ID/Investigator# 7070
      • Las Vegas, Nevada, Forenede Stater, 89104
        • Site Reference ID/Investigator# 7106
      • Las Vegas, Nevada, Forenede Stater, 89106
        • Site Reference ID/Investigator# 7518
      • Las Vegas, Nevada, Forenede Stater, 89146
        • Site Reference ID/Investigator# 7119
      • Las Vegas, Nevada, Forenede Stater, 89148
        • Site Reference ID/Investigator# 7129
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Site Reference ID/Investigator# 7071
      • Cincinnati, Ohio, Forenede Stater, 45219
        • Site Reference ID/Investigator# 7100
      • Cincinnati, Ohio, Forenede Stater, 45224
        • Site Reference ID/Investigator# 14321
      • Cincinnati, Ohio, Forenede Stater, 45245
        • Site Reference ID/Investigator# 21355
      • Cincinnati, Ohio, Forenede Stater, 45246
        • Site Reference ID/Investigator# 7074
      • Cincinnati, Ohio, Forenede Stater, 45249
        • Site Reference ID/Investigator# 7065
      • Dayton, Ohio, Forenede Stater, 45439
        • Site Reference ID/Investigator# 7075
      • Kettering, Ohio, Forenede Stater, 45429
        • Site Reference ID/Investigator# 24802
      • Mason, Ohio, Forenede Stater, 45040
        • Site Reference ID/Investigator# 7068
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • Site Reference ID/Investigator# 7104
      • Carrollton, Texas, Forenede Stater, 75006-5810
        • Site Reference ID/Investigator# 7060
      • Dallas, Texas, Forenede Stater, 75230
        • Site Reference ID/Investigator# 15282
      • Dallas, Texas, Forenede Stater, 75231
        • Site Reference ID/Investigator# 6745
      • Dallas, Texas, Forenede Stater, 75231
        • Site Reference ID/Investigator# 7083
      • Dallas, Texas, Forenede Stater, 75231
        • Site Reference ID/Investigator# 7127
      • Dallas, Texas, Forenede Stater, 75251
        • Site Reference ID/Investigator# 7110
      • Deer Park, Texas, Forenede Stater, 77536
        • Site Reference ID/Investigator# 21356
      • Fort Worth, Texas, Forenede Stater, 76116
        • Site Reference ID/Investigator# 11923
      • Houston, Texas, Forenede Stater, 77002
        • Site Reference ID/Investigator# 7321
      • Houston, Texas, Forenede Stater, 77024
        • Site Reference ID/Investigator# 21354
      • Houston, Texas, Forenede Stater, 77030
        • Site Reference ID/Investigator# 21358
      • Houston, Texas, Forenede Stater, 77030
        • Site Reference ID/Investigator# 26482
      • Houston, Texas, Forenede Stater, 77030
        • Site Reference ID/Investigator# 7079
      • Houston, Texas, Forenede Stater, 77030
        • Site Reference ID/Investigator# 7096
      • Houston, Texas, Forenede Stater, 77036
        • Site Reference ID/Investigator# 7126
      • Houston, Texas, Forenede Stater, 77036
        • Site Reference ID/Investigator# 8186
      • Houston, Texas, Forenede Stater, 77074
        • Site Reference ID/Investigator# 11323
      • Houston, Texas, Forenede Stater, 77081
        • Site Reference ID/Investigator# 7130
      • Irving, Texas, Forenede Stater, 75039
        • Site Reference ID/Investigator# 11924
      • Irving, Texas, Forenede Stater, 75061
        • Site Reference ID/Investigator# 13863
      • McKinney, Texas, Forenede Stater, 75069
        • Site Reference ID/Investigator# 7099
      • New Braunfels, Texas, Forenede Stater, 78130
        • Site Reference ID/Investigator# 19121
      • Pearland, Texas, Forenede Stater, 77584
        • Site Reference ID/Investigator# 26244
      • Plano, Texas, Forenede Stater, 75024
        • Site Reference ID/Investigator# 7105
      • San Antonio, Texas, Forenede Stater, 78205
        • Site Reference ID/Investigator# 7061
      • San Antonio, Texas, Forenede Stater, 78215
        • Site Reference ID/Investigator# 7320
      • San Antonio, Texas, Forenede Stater, 78218
        • Site Reference ID/Investigator# 7914
      • San Antonio, Texas, Forenede Stater, 78229-4801
        • Site Reference ID/Investigator# 7058
      • San Antonio, Texas, Forenede Stater, 78229
        • Site Reference ID/Investigator# 18402
      • San Antonio, Texas, Forenede Stater, 78229
        • Site Reference ID/Investigator# 7052
      • San Antonio, Texas, Forenede Stater, 78229
        • Site Reference ID/Investigator# 7062
      • San Antonio, Texas, Forenede Stater, 78238-1434
        • Site Reference ID/Investigator# 22947

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

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with mixed dyslipidemia
  • Qualifying cIMT thickness

Exclusion Criteria:

  • Patients with certain chronic or unstable medical conditions.
  • Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
  • Pregnant or lactating women or women intending to become pregnant
  • Patients with diabetes mellitus that is poorly controlled

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Capsule
Andre navne:
  • Fenofibrinsyre
  • Choline fenofibrate
Capsule
Placebo komparator: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Kapsel
Capsule

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
Tidsramme: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
Tidsramme: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)
Tidsramme: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)
Tidsramme: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)
Tidsramme: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: Maureen Kelly, MD, AbbVie

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.

Hjælpsomme links

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

1. februar 2008

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

5. februar 2008

Først indsendt, der opfyldte QC-kriterier

14. februar 2008

Først opslået (Skøn)

15. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2018

Sidst verificeret

1. december 2013

Mere information

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 .

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