Phase 3
N=93
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
Non-valvular Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01857622 ↗Enrolled (actual)
93
Serious AEs
5.4%
Results posted
Jan 2015
Primary outcome: Primary: Incidence of Any Adjudicated Bleeding Events — 20.0; 22.7; 23.8 percentage of subjects with bleeds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DU-176b 15mg (Drug); DU-176b 30mg (Drug); DU-176b 60mg (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Any Adjudicated Bleeding Events |
20.0; 22.7; 23.8 | — |
Summary
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).
Eligibility Criteria
Inclusion Criteria
- Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.
Exclusion Criteria
- Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
- Patients who are at a significantly high risk for bleeding
- Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
- Patients who have evidence of hepatic function test abnormalities
Data sourced from ClinicalTrials.gov (NCT01857622). 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.