Status:
COMPLETED
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT00829933
Start Date
March 1 2007
End Date
September 1 2008
Last Update
February 25 2019
Active Locations (1)
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1
Tokyo, Japan