Phase 2
N=536
Late Phase 2 Study of DU-176b in Patients With Non-Valvular Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00829933 ↗Enrolled (actual)
536
Serious AEs
2.9%
Results posted
Jan 2015
Primary outcome: Primary: 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. — 18.5; 22.4; 27.7; 20.0 percent of subjects with bleeding event — p=0.429
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DU-176b tablets (Drug); Warfarin potassium tablets (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
18.5; 22.4; 27.7; 20.0 | 0.429 |
| SECONDARY 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. |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Pharmacodynamic Parameters (PT, PT-INR, and APTT) |
— | — |
| SECONDARY Plasma DU-176 Concentration |
— | — |
| SECONDARY Pharmacodynamic Biomarkers (F1+2, TAT, and D-dimer ) |
— | — |
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 (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.
Eligibility Criteria
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 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).
Data sourced from ClinicalTrials.gov (NCT00829933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.