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Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension

2 de abril de 2012 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

224

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Ambrisentan
Droga: Ambrisentan
Oral tablets taken once daily.
Otros nombres:
  • Letairis
  • Volibris

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD)
Periodo de tiempo: Baseline to Week 24
Baseline to Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline to Week 24 in Borg Dyspnea Index
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Baseline to Week 24
Baseline to Week 24
Percent Change From Baseline to Week 48 in BNP
Periodo de tiempo: Baseline to Week 48
Baseline to Week 48
Change From Baseline to Week 24 in WHO Functional Class
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to Week 24
Defined as not dying during study participation
Baseline to Week 24
Long-term Survival
Periodo de tiempo: Baseline to Week 48
Defined as not dying during study participation
Baseline to Week 48

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Gilead Sciences

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2006

Finalización primaria (Actual)

1 de julio de 2008

Finalización del estudio (Actual)

1 de mayo de 2009

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2006

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2006

Publicado por primera vez (Estimar)

25 de septiembre de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de abril de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

2 de abril de 2012

Última verificación

1 de abril de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AMB-323
  • ARIES-3

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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