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- Ensayo clínico NCT00829933
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Tokyo, Japón
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Patients with non-valvular atrial fibrillation who meet all of the following requirements will be considered for admission to the study:
- Age≧20years
- Atrial fibrillation confirmed by at least 2 electrocardiographic(ECG) tracings taken at an interval of ≧1week during the year before enrollment
Presence of any (at least )one of the following risk factors for embolism:
- Hypertension
- Diabetes mellitus
- Congestive heart failure
- Previous transient ischemic attack (TIA) or cerebral infarction (more than 30 days before giving informed consent )
- Age≧75 years
- At time of giving informed consent.
- To be confirmed on ECG charts, etc.
Exclusion Criteria:
Presence of any of the following conditions with increased risk of hemorrhage:
- History of intracranial, intraocular (excluding bleeding beneath the bulbar conjunctiva ), intrathecal, retroperitoneal, or non-traumatic intraarticular hemorrhage
- History of gastrointestinal hemorrhage during the year before giving informed consent
- History of peptic ulcers during the 90 days before giving informed consent
- Surgical treatment or trauma requiring hospitalization during the 30 days before giving informed consent
- Hemoglobin level <10 g/dL platelet count <10 ×10000 /μL at screening examinations
- Active hemorrhage* present at giving informed consent or at enrollment
- Any invasive therapeutic or diagnostic procedure (e.g., surgery, tissue, biopsy, and tooth extraction) scheduled during the period from the time of informed consent until completion of the trial treatment.
- Any congenital hemorrhagic disease
- History of cerebral infarction or TIA within 30 days before giving informed consent
- Current treatment with any anticoagulant(other than warfarin)
- Concurrent rheumatic valvular disease
- History of valvular surgery
- Concurrent infectious endocarditis
- Concurrent cardiac myxoma
- Confirmed left ventricular or left atrial thrombosis
- Any congenital condition with a tendency toward thrombosis
- Electrical or pharmacological defibrillation scheduled during the trial treatment
- Uncontrolled hypertension (persistently high systolic [>160mmHg]or diastolic [>100mmHg] pressure)
- Uncontrolled diabetes mellitus
Renal or hepatic dysfunction (as defined below ), confirmed at screening examinations
- Serum creatinine>1.5mg/dL
- AST(GOT)or ALT(GPT)≧twice the upper limit of the reference range
- Total bilirubin ≧twice the upper limit of the reference range
- Current antiplatelet therapy for any concomitant illness that may be aggravated after discontinuation of the therapy.
- Any concurrent severe cardiac disease
- Known allergy to warfarin or any condition contraindicating its use
- Inability to discontinue current treatment with vitamin K
- Confirmed or potential pregnancy, wish to become pregnant during the study period, or current breast feeding
- Previous treatment with DU-176b
- Participation in a trial of any other drug during the 6 month before giving informed consent
- Any other condition that disqualifies the patient for the study in the opinion of the investigator/subinvestigator *This includes ecchymosis identified as at least one hematoma sized ≧5 cm in longer diameter, macroscopic hematuria, and microscopic hematuria defined as a ≧2+test or a 1+ test for occult blood with a urine sediment containing ≧10 red cells per high-power field (except for a 2+ occult blood test persisting for 1 year before giving informed consent).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
DU-176b low dose
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DU-176b tablets taken once daily for up to 12 weeks
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Experimental: 2
DU-176b intermediate dose
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DU-176b tablets taken once daily for up to 12 weeks
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Experimental: 3
DU-176b high dose
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DU-176b tablets taken once daily for up to 12 weeks
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Comparador activo: 4
Warfarin
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Warfarin potassium tablets taken once daily for up to 12 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Bleeding Events (Major Bleeding, Clinically Relevant Non-major Bleeding and Minor Bleeding ) Identified During the Period From the Entry Into the Treatment Period Until Completion or Termination of the Treatment.
Periodo de tiempo: 12 weeks
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The primary endpoint was the incidence of bleeding events (major bleeding, clinically relevant non-major bleeding, or minor bleeding) that occurred during the treatment period.
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Thromboembolic Events (Cerebral Infarction and Systemic Embolism) Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment.
Periodo de tiempo: 12 weeks
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12 weeks
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Incidence of Adverse Events and Adverse Reactions Identified During the Period From the Entry to the Treatment Period Until Completion or Termination of the Treatment
Periodo de tiempo: 12 weeks
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12 weeks
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Pharmacodynamic Parameters (PT, PT-INR, and APTT)
Periodo de tiempo: 12 weeks
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PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time
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12 weeks
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Plasma DU-176 Concentration
Periodo de tiempo: 12 weeks
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12 weeks
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Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Periodo de tiempo: 12 weeks
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Arritmias Cardiacas
- Fibrilación auricular
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Inhibidores del factor Xa
- Antitrombinas
- Inhibidores de la serina proteinasa
- Anticoagulantes
- Edoxabán
- Warfarina
Otros números de identificación del estudio
- DU176b-C-J225
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
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. .
Ensayos clínicos sobre Fibrilación auricular
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The Second Affiliated Hospital of Chongqing Medical...TerminadoFibrilación auricular | Hipertensión,Esencial | Dilatación atrial izquierdaPorcelana
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Region SkaneReclutamientoFibrilación auricular | Dilatación atrial izquierdaSuecia
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Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)ReclutamientoEnfermedades Renales | Hipertensión | Obesidad Pediátrica | Proteinuria | Albuminuria | Lesión renal | Trastornos de la presión arterial | Disfunción autonómica | Enfermedad renal pediátrica | Disfunción Ventricular Izquierda | Hipertrofia del ventrículo izquierdo | Disfunción renal | Desequilibrio autonómico | Disfunción... y otras condicionesEstados Unidos
Ensayos clínicos sobre DU-176b tablets
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Daiichi Sankyo Co., Ltd.TerminadoFibrilación auricular no valvularJapón
-
Pakistan Society for Rehabilitation of Differently...Innovative Health Concepts and Research Center, Lahore,Pakistan; Department of...Aún no reclutando
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Daiichi Sankyo, Inc.TerminadoTrombosis | Artroplastia, Reemplazo, CaderaEstados Unidos
-
ALK-Abelló A/STerminadoAlergia al polen de abedulFinlandia, Países Bajos
-
ALK-Abelló A/SMerck Sharp & Dohme LLCTerminadoRinitis, Alérgica, Perenne | Rinitis, Alérgica, No Estacional
-
ALK-Abelló A/SErgomed; ACM Pivotal Global Central LaboratoryTerminado
-
Daiichi Sankyo Co., Ltd.TerminadoLa trombosis venosa profunda | Tromboembolismo venoso | Artroplastia total de rodillaJapón
-
LifeBridge HealthDaiichi Sankyo, Inc.DesconocidoInsuficiencia cardiacaEstados Unidos
-
ALK-Abelló A/SMerck Sharp & Dohme LLCTerminadoRinitis, Alérgica, Perenne | Rinitis, Alérgica, No Estacional