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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

682

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

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

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

45 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Legemiddel: ABT-335
Capsule
Andre navn:
  • Fenofibrinsyre
  • Choline fenofibrate
Annen: Atorvastatin
Capsule
Placebo komparator: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Legemiddel: Placebo
Kapsel
Annen: Atorvastatin
Capsule

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

AbbVie (prior sponsor, Abbott)

Etterforskere

  • Studieleder: Maureen Kelly, MD, AbbVie

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

Hjelpsomme linker

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. februar 2008

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. september 2012

Datoer for studieregistrering

Først innsendt

5. februar 2008

Først innsendt som oppfylte QC-kriteriene

14. februar 2008

Først lagt ut (Anslag)

15. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2018

Sist bekreftet

1. desember 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • M10-158

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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