- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
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Tokyo, Japan
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
DU-176b low dose
|
DU-176b tablets taken once daily for up to 12 weeks
|
Eksperimentel: 2
DU-176b intermediate dose
|
DU-176b tablets taken once daily for up to 12 weeks
|
Eksperimentel: 3
DU-176b high dose
|
DU-176b tablets taken once daily for up to 12 weeks
|
Aktiv komparator: 4
Warfarin
|
Warfarin potassium tablets taken once daily for up to 12 weeks
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: 12 weeks
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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
Tidsramme: 12 weeks
|
12 weeks
|
|
Pharmacodynamic Parameters (PT, PT-INR, and APTT)
Tidsramme: 12 weeks
|
PT - prothrombin time INR - International Normalized Ratio APTT - Activated Partial Thromboplastin time
|
12 weeks
|
Plasma DU-176 Concentration
Tidsramme: 12 weeks
|
12 weeks
|
|
Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer )
Tidsramme: 12 weeks
|
12 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DU176b-C-J225
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
-
W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
-
Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
-
Henry Ford Health SystemTrukket tilbage
-
Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
-
HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
-
Occlutech International ABAfsluttetSecundum atrial septal defekter
-
University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
Kliniske forsøg med DU-176b tablets
-
Daiichi Sankyo Co., Ltd.AfsluttetIkke-valvulær atrieflimrenJapan
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRekruttering
-
Daiichi Sankyo, Inc.AfsluttetTrombose | Artroplastik, udskiftning, hofteForenede Stater
-
Daiichi Sankyo Co., Ltd.Afsluttet
-
Daiichi Sankyo Co., Ltd.AfsluttetDyb venetrombose | Venøs tromboembolisme | Total knæarthroplastikJapan
-
Daiichi Sankyo Co., Ltd.AfsluttetSlag | AtrieflimrenTaiwan, Korea, Republikken, Singapore, Kina
-
LifeBridge HealthDaiichi Sankyo, Inc.Ukendt
-
Daiichi Sankyo Co., Ltd.AfsluttetVenøs tromboembolismeJapan
-
Daiichi Sankyo, Inc.AfsluttetKræft | Venøs tromboembolisme (VTE) | Dyb venetrombose (DVT) | Lungeemboli (PE)Forenede Stater, Holland, Italien, Belgien, Frankrig, Ungarn
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Daiichi Sankyo, Inc.AfsluttetVenøs trombose | Tromboemboli | Venøs tromboembolisme | Dyb venetrombose (DVT) | Lungeemboli (PE)Frankrig, Forenede Stater, Japan, Danmark, Italien, Den Russiske Føderation, Tjekkiet, Tyskland, Indien, Israel, Filippinerne, Taiwan, Ukraine, Australien, Østrig, Kina, Argentina, Hviderusland, Belgien, Brasilien, Canada, Chile, Est... og mere