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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 giugno 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

682

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

45 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Droga: ABT-335
Capsule
Altri nomi:
  • Acido fenofibrico
  • Choline fenofibrate
Altro: Atorvastatin
Capsule
Comparatore placebo: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Droga: Placebo
Capsula
Altro: Atorvastatin
Capsule

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigatori

  • Direttore dello studio: Maureen Kelly, MD, AbbVie

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2008

Completamento primario (Effettivo)

1 settembre 2012

Completamento dello studio (Effettivo)

1 settembre 2012

Date di iscrizione allo studio

Primo inviato

5 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

14 febbraio 2008

Primo Inserito (Stima)

15 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2018

Ultimo verificato

1 dicembre 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • M10-158

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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