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Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

maanantai 2. huhtikuuta 2012 päivittänyt: Gilead Sciences

ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in a broad population of participants with pulmonary hypertension (PH). Secondary objectives of this study were to evaluate the effects of ambrisentan on other clinical measures of pulmonary arterial hypertension (PAH), long-term treatment success, and survival.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

This study was to enroll up to 200 participants with PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5). Participants with left heart disease or left heart failure were excluded (WHO Group 2). Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

224

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Australia
      • Perth, Australia, 6000
        • Royal Perth Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T1Y 6J4
        • Peter Lougheed Centre
      • Edmonton, Alberta, Kanada, T6G 2B7
        • University Of Alberta Hospitals
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2N2
        • Toronto General Hospital
  • Yhdysvallat
    • Alabama
      • Birmingham, Alabama, Yhdysvallat, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, Yhdysvallat, 85013
        • Arizona Pulmonary Specialists, Ltd
    • California
      • La Jolla, California, Yhdysvallat, 92037
        • UCSD Medical Center, Thornton Hospital
      • Los Angeles, California, Yhdysvallat, 90073
        • Greater Los Angeles, VA Medical Center
      • Torrance, California, Yhdysvallat, 90502
        • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, Yhdysvallat, 80045
        • University of Colorado Health Sciences Center
    • Connecticut
      • Farmington, Connecticut, Yhdysvallat, 06030
        • University of Connecticut Health Center
    • Florida
      • Miami Beach, Florida, Yhdysvallat, 33140
        • Pulmonary Hypertension Clinic Mount Sinai Medical Center
      • Sarasota, Florida, Yhdysvallat, 34233
        • Suncoast Lung Center
    • Georgia
      • Augusta, Georgia, Yhdysvallat, 30912
        • Medical College of Georgia
      • Decatur, Georgia, Yhdysvallat, 30030
        • Atlanta Institute for Medical Research, Inc.
    • Illinois
      • Chicago, Illinois, Yhdysvallat, 60637
        • University of Chicago Hospitals
    • Iowa
      • Iowa City, Iowa, Yhdysvallat, 52242
        • University of Iowa Hospitals and Clinics
    • Maryland
      • Baltimore, Maryland, Yhdysvallat, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Yhdysvallat, 02118
        • Boston University School of Medicine
      • Boston, Massachusetts, Yhdysvallat, 02111
        • Tufts-New England Medical Center
      • Boston, Massachusetts, Yhdysvallat, 02115
        • Boston Adult Congenital Heart Service
    • Minnesota
      • Rochester, Minnesota, Yhdysvallat, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Yhdysvallat, 63110
        • Washington University School of Medicine
    • New Jersey
      • Newark, New Jersey, Yhdysvallat, 07112
        • Newark Beth Israel Medical Center
      • Newark, New Jersey, Yhdysvallat, 07103
        • University of Medicine & Dentistry of New Jersey
    • New York
      • New York, New York, Yhdysvallat, 10032
        • New York Presbyterian Pulmonary Hypertension Center
      • Rochester, New York, Yhdysvallat, 14623
        • Mary Parkes Asthma Center
    • North Carolina
      • Durham, North Carolina, Yhdysvallat, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Yhdysvallat, 45219
        • The Lindner Clinical Trial Center
      • Cleveland, Ohio, Yhdysvallat, 44106
        • University Hospitals of Cleveland
    • Oregon
      • Portland, Oregon, Yhdysvallat, 97210
        • Legacy Clinical Northwest
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Yhdysvallat, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Yhdysvallat, 15213
        • University of Pittsburgh Medical Center Presbyterian
    • Rhode Island
      • Providence, Rhode Island, Yhdysvallat, 02903
        • Rhode Island Hospital
    • South Carolina
      • Lexington, South Carolina, Yhdysvallat, 29072
        • Lexington Pulmonary and Critical Care
    • Texas
      • Houston, Texas, Yhdysvallat, 77030
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, Yhdysvallat, 22908
        • University of Virginia Health Sciences Center

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Summarized Inclusion Criteria:

  1. 18 years of age or older
  2. Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5).
  3. Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor therapy
  4. Right heart catheterization completed prior to screening must meet pre-specified criteria
  5. Female participants of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.
  6. Male participants must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.

Summarized Exclusion Criteria:

  1. Participation in a previous clinical study with ambrisentan
  2. Bosentan or sitaxsentan use within four weeks prior to the screening visit
  3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is greater than 3 times the upper limit of normal at the screening visit
  4. Pulmonary function tests not meeting the following pre-specified criteria: 1) mean pulmonary arterial pressure (PAP) >= 25 mm Hg; 2) PVR > 3 mm Hg/L/min; 3) pulmonary capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) < 15 mm Hg; 4) total lung capacity (TLC) >= 70% of predicted normal for participants without ILD or >= 60% of predicted normal in participants with ILD; forced expiratory volume in 1 second (FEV1) >= 65% of predicted normal in participants without COPD or >= 50% of predicted normal in participants with COPD
  5. Contraindication to treatment with endothelin receptor antagonist (ERA)
  6. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
  7. Female participant who is pregnant or breastfeeding

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Ambrisentan
Lääke: Ambrisentan
Oral tablets taken once daily.
Muut nimet:
  • Letairis
  • Volibris

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Aikaikkuna
Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)
Aikaikkuna: Baseline to Week 24
Baseline to Week 24

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change From Baseline to Week 24 in Borg Dyspnea Index
Aikaikkuna: Baseline to Week 24
Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.
Baseline to Week 24
Change From Baseline to Week 48 in Borg Dyspnea Index
Aikaikkuna: Baseline to Week 48
Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.
Baseline to Week 48
Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)
Aikaikkuna: Baseline to Week 24
Baseline to Week 24
Percent Change From Baseline to Week 48 in BNP
Aikaikkuna: Baseline to Week 48
Baseline to Week 48
Change From Baseline to Week 24 in WHO Functional Class
Aikaikkuna: Baseline to Week 24
Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.
Baseline to Week 24
Change From Baseline to Week 48 in WHO Functional Class
Aikaikkuna: Baseline to Week 48
Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.
Baseline to Week 48
Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale
Aikaikkuna: Baseline to Week 24
Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.
Baseline to Week 24
Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale
Aikaikkuna: Baseline to Week 48
Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.
Baseline to Week 48
Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24
Aikaikkuna: Baseline to Week 24
Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents
Baseline to Week 24
Percent of Participants With no Clinical Worsening of PH at Week 48
Aikaikkuna: Baseline to Week 48
Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents
Baseline to Week 48
Failure-free Treatment Status
Aikaikkuna: Baseline to Week 24
Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents
Baseline to Week 24
Failure-free Treatment Status
Aikaikkuna: Baseline to Week 48
Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents
Baseline to Week 48
Monotherapy Treatment Status
Aikaikkuna: Baseline to Week 24
Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment
Baseline to Week 24
Monotherapy Treatment Status
Aikaikkuna: Baseline to Week 48
Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment
Baseline to Week 48
Long-term Survival
Aikaikkuna: Baseline to Week 24
Defined as not dying during study participation
Baseline to Week 24
Long-term Survival
Aikaikkuna: Baseline to Week 48
Defined as not dying during study participation
Baseline to Week 48

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Gilead Sciences

Tutkijat

  • Päätutkija: Lewis J Rubin, MD, University of California, San Diego

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Tiistai 1. elokuuta 2006

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. heinäkuuta 2008

Opintojen valmistuminen (Todellinen)

Perjantai 1. toukokuuta 2009

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 21. syyskuuta 2006

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 21. syyskuuta 2006

Ensimmäinen Lähetetty (Arvio)

Maanantai 25. syyskuuta 2006

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Torstai 5. huhtikuuta 2012

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. huhtikuuta 2012

Viimeksi vahvistettu

Sunnuntai 1. huhtikuuta 2012

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • AMB-323
  • ARIES-3

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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