At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Betrixabandrug
Likely dose
Betrixaban 80 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.
In Brief
A Phase 1 clinical trial evaluating Betrixaban for Renal Impairment. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesGermany
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedOct 2009
Primary CompletionFeb 2010
TodayJul 2026
First PostedOct 21, 2009
Enrollment StartJul 31, 2009
Primary CompletionFeb 28, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.7 years ago
Interventions
Betrixabandrug
80 mg betrixaban qd for 8 days