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A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

18 de fevereiro de 2014 atualizado por: Boehringer Ingelheim

Open Label, Randomised Exploratory Dose Response Study in Pharmacodynamics and Safety of BIBR 1048 (110 mg Twice Daily (b.i.d.) and 150 mg b.i.d.) for 12 Weeks in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin

The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

174

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Japão
      • Aki-gun, Hiroshima, Japão
        • 1160.49.024 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japão
        • 1160.49.025 Boehringer Ingelheim Investigational Site
      • Fukuoka, Fukuoka, Japão
        • 1160.49.026 Boehringer Ingelheim Investigational Site
      • Himeji, Hyogo, Japão
        • 1160.49.021 Boehringer Ingelheim Investigational Site
      • Iizuka,Fukuoka, Japão
        • 1160.49.027 Boehringer Ingelheim Investigational Site
      • Kyoto, Kyoto, Japão
        • 1160.49.013 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japão
        • 1160.49.011 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi, Japão
        • 1160.49.012 Boehringer Ingelheim Investigational Site
      • Naka-gun, Ibaragi, Japão
        • 1160.49.004 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama, Japão
        • 1160.49.022 Boehringer Ingelheim Investigational Site
      • Okayama, Okayama, Japão
        • 1160.49.023 Boehringer Ingelheim Investigational Site
      • Oota, Tokyo, Japão
        • 1160.49.006 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japão
        • 1160.49.016 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japão
        • 1160.49.017 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japão
        • 1160.49.018 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka, Japão
        • 1160.49.019 Boehringer Ingelheim Investigational Site
      • Sakai, Osaka, Japão
        • 1160.49.020 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japão
        • 1160.49.001 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido, Japão
        • 1160.49.028 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi, Japão
        • 1160.49.002 Boehringer Ingelheim Investigational Site
      • Shinjuku, Tokyo, Japão
        • 1160.49.005 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japão
        • 1160.49.014 Boehringer Ingelheim Investigational Site
      • Suita, Osaka, Japão
        • 1160.49.015 Boehringer Ingelheim Investigational Site
      • Tokorozawa, Saitama, Japão
        • 1160.49.007 Boehringer Ingelheim Investigational Site
      • Toyama, Toyama, Japão
        • 1160.49.009 Boehringer Ingelheim Investigational Site
      • Tsuchiura, Ibaragi, Japão
        • 1160.49.003 Boehringer Ingelheim Investigational Site
      • Ueda, Nagano, Japão
        • 1160.49.029 Nagano National Hospital
      • Yokohama, Kanagawa, Japão
        • 1160.49.008 Boehringer Ingelheim Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion criteria Inclusion criteria

  1. Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)

  2. Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:

    • Hypertension
    • Diabetes mellitus
    • Left-side heart failure
    • A previous ischemic stroke or transient ischemic attack
    • Age 75 years or older
    • A history of coronary artery diseases

Exclusion criteria Exclusion criteria

  1. Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
  2. Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
  3. Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
  4. Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
  5. Patients with atrial myxoma or left ventricular thrombosis
  6. Patients with contraindication to anticoagulant therapies
  7. Patients scheduled for major surgery or invasive procedure
  8. Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
  9. Patients with uncontrolled hypertension

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dabigatran etexilate 220 mg daily
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Medicamento: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Medicamento: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Experimental: Dabigatran etexilate 300 mg daily
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Medicamento: Dabigatran etexilate
Dabigatran etexilate 110 mg capsule, twice a day, oral administration
Medicamento: Dabigatran etexilate
Dabigatran etexilate 150 mg capsule, twice a day, oral administration
Comparador Ativo: Warfarin
Dose-adjusted warfarin based on target INR values
Medicamento: Varfarina
Varfarina com dose ajustada com base nos valores alvo de INR

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Frequency (Occurrence Rates) of Major Bleeding Event
Prazo: upto 15 weeks

The percentage of patients with major bleeding event.

Major bleeding was defined as any bleed fulfilling one of the following conditions:

  • Fatal or life-threatening
  • Retroperitoneal, intracranial, intraocular, or intraspinal bleeding (verified by objective testing)
  • Bleeding requiring surgical treatment
  • Clinically overt bleeding leading to a transfusion (erythrocyte component transfusion or whole blood transfusion) of 4.5 units (equal to 2 units in EU/US) or more
  • Clinically overt bleeding leading to a fall in haemoglobin of at least 2 g/dL
upto 15 weeks
Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event
Prazo: upto 15 weeks

The percentage of patients with clinically relevant bleeding event.

Any bleed that did not qualify as a major bleed was defined as a minor bleed; minor bleed which fulfilled one of the criteria below was defined as a clinically relevant bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
upto 15 weeks
Frequency (Occurrence Rates) of Nuisance Bleeding Event
Prazo: Upto 15 weeks

The percentage of patients with nuisance bleeding event

Any bleed that did not qualify as a major bleed was defined as a minor bleed; all minor bleeding events not fulfilling one of the criteria below was defined as a nuisance bleeding event:

  • A skin haematoma of at least 25 sqcm
  • Spontaneous nose bleed lasting for more than 5 minutes
  • Macroscopic haematuria (either spontaneous or, if associated with an intervention, lasting more than 24 hours)
  • Spontaneous rectal bleeding (more than spotting on toilet paper)
  • Gingival bleeding lasting for more than 5 minutes
  • Bleeding leading to hospitalisation
  • Bleeding leading to blood transfusion (erythrocyte component transfusion or whole blood transfusion) of less than 4.5 units (equal to 2 units in EU/US)
  • Any other bleeding considered clinically relevant by the investigator
Upto 15 weeks
Incidence and Severity of Adverse Events
Prazo: Upto 15 weeks
Intensity of event is categorised as mild, moderate and severe.
Upto 15 weeks
Discontinuation of the Study Drug Due to Adverse Events
Prazo: Upto 15 weeks
Discontinuation of the study drug due to adverse events.
Upto 15 weeks
Changes in Laboratory Test Values
Prazo: 12 weeks
The number of patients with ALT, AST, alkaline phosphatase, or bilirubin exceeded the upper limit of normal (ULN) range
12 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Frequency (Occurrence Rates) of a Composite Clinical Endpoint.
Prazo: Upto 15 weeks
Percentage of patients with the composite clinical endpoint (ischemic or haemorrhagic stroke (fatal or non-fatal), transient ischemic attacks, systemic embolism, myocardial infarction (fatal or non-fatal), other major adverse cardiac events, and death)
Upto 15 weeks
Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal)
Prazo: Upto 15 weeks
The percentage of patients with ischemic or haemorrhagic stroke (fatal or non-fatal)
Upto 15 weeks
Frequency (Occurrence Rates) of Transient Ischemic Attack
Prazo: Upto 15 weeks
The percentage of patients with transient ischemic attack
Upto 15 weeks
Frequency (Occurrence Rates) of Systemic Embolism
Prazo: Upto 15 weeks
The percentage of patients with systemic embolism
Upto 15 weeks
Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal)
Prazo: Upto 15 weeks
The percentage of patients with myocardial infarction (fatal or non-fatal)
Upto 15 weeks
Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events
Prazo: Upto 15 weeks
The percentage of patients with other major adverse cardiac events
Upto 15 weeks
Frequency (Occurrence Rates) of Death
Prazo: Upto 15 weeks
The percentage of patients with death
Upto 15 weeks
Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time)
Prazo: Week 0,1,4 and 12
The blood coagulation parameter aPTT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough ECT (Ecarin Clotting Time)
Prazo: Week 0,1,4 and 12
The blood coagulation parameter ECT was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough INR (International Normalised Ratio)
Prazo: Week 0,1,4 and 12
The blood coagulation parameter INR was assessed in patients allocated to the dabigatran etexilate groups at week 0, prior to drug administration and at the trough at week 1, 4 and 12.
Week 0,1,4 and 12
Anticoagulation Effects Trough 11-dehydrothromboxane B2
Prazo: Week 0 and 12
Analysis based on concomitant use of aspirin compared to no aspirin users. 11-dehydrothromboxane B2 is measured in urine of patients.
Week 0 and 12
Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration
Prazo: Week 1,4 and 12
Week 1,4 and 12

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Boehringer Ingelheim

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2005

Conclusão Primária (Real)

1 de setembro de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

19 de maio de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2010

Primeira postagem (Estimativa)

3 de junho de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

19 de março de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de fevereiro de 2014

Última verificação

1 de fevereiro de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 1160.49

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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