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A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension (STRIDE-3)

29 de marzo de 2012 actualizado por: Pfizer

A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension

This is a multi-center, open-label study of sitaxsentan sodium 100 mg taken orally once daily by subjects with PAH until sitaxsentan, in a particular country or region, is commercially available for the treatment of PAH or the study is closed.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Open-label extension

Tipo de estudio

Intervencionista

Inscripción (Actual)

1192

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

  • Alemania
      • Berlin, Alemania, 14050
        • Pfizer Investigational Site
      • Dresden, Alemania, 01307
        • Pfizer Investigational Site
      • Giessen, Alemania, 35392
        • Pfizer Investigational Site
      • Greifswald, Alemania, 17487
        • Pfizer Investigational Site
      • Hannover, Alemania, 30625
        • Pfizer Investigational Site
      • Heidelberg, Alemania, 69120
        • Pfizer Investigational Site
      • Leipzig, Alemania, 04103
        • Pfizer Investigational Site
      • Regensburg, Alemania, 93053
        • Pfizer Investigational Site
  • Argentina
      • Capital Federal, Argentina, C1039AAO
        • Pfizer Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1416ASA
        • Pfizer Investigational Site
  • Australia
      • Chermside, Australia, QLD 4032
        • Pfizer Investigational Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Pfizer Investigational Site
    • Queensland
      • Chermside Q, Queensland, Australia, 4032
        • Pfizer Investigational Site
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Pfizer Investigational Site
  • Austria
      • Graz, Austria, 8036
        • Pfizer Investigational Site
      • Wien, Austria, 1090
        • Pfizer Investigational Site
  • Brasil
      • Sao Paulo, Brasil, 05403-000
        • Pfizer Investigational Site
    • MG
      • Belo Horizonte, MG, Brasil, 30380-090
        • Pfizer Investigational Site
    • RS
      • Porto Alegre, RS, Brasil, 90035-003
        • Pfizer Investigational Site
  • Bélgica
      • Bruxelles, Bélgica, 1070
        • Pfizer Investigational Site
      • Leuven, Bélgica, B - 3000
        • Pfizer Investigational Site
  • Canadá
      • Quebec, Canadá, G1V 4G5
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canadá, T1Y 6J4
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canadá, T6G 2B7
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canadá, N6A 4G5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canadá, M5G 2C4
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
        • Pfizer Investigational Site
  • España
      • Barcelona, España, 08036
        • Pfizer Investigational Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Estados Unidos, 35294
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85013
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, Estados Unidos, 90073
        • Pfizer Investigational Site
      • San Francisco, California, Estados Unidos, 94143-0124
        • Pfizer Investigational Site
      • Torrence, California, Estados Unidos, 90502
        • Pfizer Investigational Site
    • Colorado
      • Denver, Colorado, Estados Unidos, 80262
        • Pfizer Investigational Site
      • Denver, Colorado, Estados Unidos, 80218
        • Pfizer Investigational Site
    • Florida
      • Sarasota, Florida, Estados Unidos, 34233
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Pfizer Investigational Site
      • Augusta, Georgia, Estados Unidos, 30912
        • Pfizer Investigational Site
      • Decatur, Georgia, Estados Unidos, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, Estados Unidos, 30030
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Pfizer Investigational Site
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Estados Unidos, 70112-1393
        • Pfizer Investigational Site
    • Maine
      • Portland, Maine, Estados Unidos, 04102
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02118
        • Pfizer Investigational Site
      • Boston, Massachusetts, Estados Unidos, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, Estados Unidos, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, Estados Unidos, 02218
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109-0570
        • Pfizer Investigational Site
      • Detroit, Michigan, Estados Unidos, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, Estados Unidos, 55905
        • Pfizer Investigational Site
    • New Jersey
      • New Brunswick, New Jersey, Estados Unidos, 08903-0019
        • Pfizer Investigational Site
    • New York
      • New York, New York, Estados Unidos, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44106
        • Pfizer Investigational Site
      • Cleveland, Ohio, Estados Unidos, 44195
        • Pfizer Investigational Site
      • Columbus, Ohio, Estados Unidos, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29425
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37232
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37232-5735
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37232-2650
        • Pfizer Investigational Site
    • Texas
      • Galveston, Texas, Estados Unidos, 77555-0561
        • Pfizer Investigational Site
      • Houston, Texas, Estados Unidos, 77030
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78229
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84143
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Pfizer Investigational Site
  • Francia
      • Clamart Cedex, Francia, 92141
        • Pfizer Investigational Site
      • GRENOBLE Cedex 09, Francia, 38043
        • Pfizer Investigational Site
      • Strasbourg, Francia, 67098
        • Pfizer Investigational Site
  • Israel
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel-Hashomer, Ramat Gan, Israel, 52601
        • Pfizer Investigational Site
  • Italia
      • Bologna, Italia, 40138
        • Pfizer Investigational Site
  • México
    • CP
      • Monterrey, CP, México, 64020
        • Pfizer Investigational Site
    • DF
      • Tlalpan, DF, México, 14080
        • Pfizer Investigational Site
    • N.l.
      • Monterrey, N.l., México, 64360
        • Pfizer Investigational Site
  • Países Bajos
      • Amsterdam, Países Bajos, 1081 HV
        • Pfizer Investigational Site
  • Polonia
      • Krakow, Polonia, 31-202
        • Pfizer Investigational Site
      • Warszawa, Polonia, 01-138
        • Pfizer Investigational Site
      • Zabrze, Polonia, 41-800
        • Pfizer Investigational Site
  • Reino Unido
      • Glasgow, Reino Unido, G11 6NT
        • Pfizer Investigational Site
      • London, Reino Unido, NW3 2QG
        • Pfizer Investigational Site
      • Newcastle, Reino Unido, NE7 7DN
        • Pfizer Investigational Site
    • Cambridgeshire
      • Papworth Everard, Cambridgeshire, Reino Unido, CB3 8RB
        • Pfizer Investigational Site

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

12 años a 75 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Diagnosis of Pulmonary Arterial Hypertension (PAH) confirmed by cardiac catheterization.
  • Current diagnosis of WHO group 1 PAH with functional class 2, 3, or 4 symptoms.

Exclusion Criteria:

  • Has portal hypertension or chronic liver disease.
  • Has history of left sided heart disease or significant cardiac disease.

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

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

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Sitaxsentan
Droga: Sitaxsentan
Sitaxsentan 100 mg tablets once daily
Otros nombres:
  • Sitaxentan

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Day 1 up to 82 months
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product were reported.
Day 1 up to 82 months
The Percentage of Participants Who Experience an Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Value Greater Than (>) 3.0 Times (x) the Upper Limit of Normal Range (ULN)
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
The Percentage of Participants Who Experience an ALT and AST Value > 3.0 x ULN
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
ALT and AST data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Total Bilirubin > 1.5 x ULN
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Total builirubin data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Hematology)
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Hematology data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Chemistry)
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Chemistry data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Laboratory Test Abnormalities (Urinalysis)
Periodo de tiempo: Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Urinalysis data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 62, 68, 72, 74, 80, 84, 88, 92, 96, 100, 104, 108 and every 4 weeks to Termination up to 82 months
Percentage of Participants With Anticoagulant Use
Periodo de tiempo: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Participants with anticoagulant use before first dose or participants with anticoagulant use from first dose of sitaxsentan.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Elevated International Normalize Ratio (INR)
Periodo de tiempo: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Elevated INR in participants who took warfarin, warfarin derivatives, other anticoagulant and no anticoagulants. Elevated INR defined as > 3.5. Percentage calculated using number of participants with INR data as the denominator.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Electrocardiography (ECG) Results of Potential Clinical Importance
Periodo de tiempo: Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Standard 12-lead ECG results determined to be of potential clinical importance according to investigator clinical judgement.
Weeks 28,60,72,84,96,104, Transition Visit up to 82 months
Percentage of Participants With Vital Sign Results of Potential Clinical Importance
Periodo de tiempo: Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Vital signs include sitting blood pressure, respiration rate, heart rate and temperature. Potential clinical importance determined according to investigator clinical judgement.
Day 1, Weeks 28,60,72,84,96,104, Transition visit, every 6 months Post Transition, up to 82 months
Percentage of Participants With Abnormal Prothrombin Time (PT)
Periodo de tiempo: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
Percentage of Participants With Abnormal Partial Thromboplastin Time (PTT)
Periodo de tiempo: Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months
PTT data were analyzed by several local laboratories. There were subtle differences in the reference ranges used for analysis.
Baseline, Weeks 1 and 2, every 2 weeks up to Week 52, Amendment 4 visit, every 4 weeks up to 82 months

Colaboradores e Investigadores

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

Patrocinador

Pfizer

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 marzo de 2003

Finalización primaria (Actual)

1 de julio de 2011

Finalización del estudio (Actual)

1 de julio de 2011

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

16 de diciembre de 2008

Publicado por primera vez (Estimar)

18 de diciembre de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

24 de abril de 2012

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

29 de marzo de 2012

Última verificación

1 de noviembre de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • B1321007
  • FPH03

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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