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Clinical Trial Details

Trial ID: L0764
Source ID: NCT02289703
Associated Drug: Rivaroxaban 15 Mg
Title: A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End-Stage Renal Disease
Interventions: DRUG: Rivaroxaban 15 mg
Outcome Measures: Primary: Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban, The Cmax is the maximum observed plasma concentration., Pre-dose up to 72 hrs post-dose|Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUClast) of Rivaroxaban, The AUClast is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration., Pre-dose up to 72 hrs post-dose|Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUCinfinity) of Rivaroxaban, The AUCinfinity is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUClast and Clast/lambda(z), where AUClast is area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve., Pre-dose up to 72 hrs post-dose | Secondary: Maximum Observed Effect (Emax) for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa, Maximum observed effect (Emax) for parameters: prothrombin time (PT), factor Xa (FXa) inhibition and anti-FXa, will be assessed., Pre-dose up to 72 hrs post-dose|Area Under the Dose-Response Curve for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa, The area under the dose-response curve for parameters: prothrombin time, FXa inhibition and anti-FXa, will be assessed., Pre-dose up to 72 hrs post-dose|Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs), An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly., Screening up to end of study (Group A: maximum up to 43 days, Group B: maximum up to 25 days) or up to early withdrawal
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC | Collaborators: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 16
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-01
Completion Date: 2015-03
Results First Posted:
Last Update Posted: 2017-01-24
Locations: Knoxville, Tennessee, United States
URL: https://clinicaltrials.gov/show/NCT02289703