Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation

8 février 2019 mis à jour par: Daiichi Sankyo Co., Ltd.

A Randomized Dose-ranging Controlled Trial of DU-176b Versus Warfarin Potassium in Patients With Non-valvular Atrial Fibrillation

The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

536

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
DU-176b low dose
Médicament: DU-176b tablets
DU-176b tablets taken once daily for up to 12 weeks
Expérimental: 2
DU-176b intermediate dose
Médicament: DU-176b tablets
DU-176b tablets taken once daily for up to 12 weeks
Expérimental: 3
DU-176b high dose
Médicament: DU-176b tablets
DU-176b tablets taken once daily for up to 12 weeks
Comparateur actif: 4
Warfarin
Médicament: Warfarin potassium tablets
Warfarin potassium tablets taken once daily for up to 12 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 12 weeks
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.
12 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 12 weeks
12 weeks
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
Délai: 12 weeks
12 weeks
Pharmacodynamic Parameters (PT, PT-INR, and APTT)
Délai: 12 weeks
PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time
12 weeks
Plasma DU-176 Concentration
Délai: 12 weeks
12 weeks
Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Délai: 12 weeks
12 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Daiichi Sankyo Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2007

Achèvement primaire (Réel)

1 juillet 2008

Achèvement de l'étude (Réel)

1 septembre 2008

Dates d'inscription aux études

Première soumission

26 janvier 2009

Première soumission répondant aux critères de contrôle qualité

26 janvier 2009

Première publication (Estimation)

27 janvier 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 février 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 février 2019

Dernière vérification

1 février 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • DU176b-C-J225

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Délai de partage IPD

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Critères d'accès au partage IPD

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur DU-176b tablets

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Peru

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
S'abonner