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Clinical Trial Details

Trial ID: L0783
Source ID: NCT01568775
Associated Drug: Aliskiren
Title: Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: End Stage Renal Disease
Interventions: DRUG: Aliskiren
Outcome Measures: Primary: Measure: Pharmacokinetics of aliskiren: Area under the concentration-time curve from time zero to 48- hour post-dose (AUC(0-48hrs)), from time zero to the last measurable concentration sampling time (AUClast), from time zero to infinity (AUCinf), Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed., 48 hours (period 1) , 1 hour (Period 2)|Pharmacokinetics of aliskiren: Maximum (peak) observed blood and urine drug concentration (Cmax) after single dose administration, Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed., 48 hours (period 1) , 1 hour (Period 2)|Pharmacokinetics of aliskiren: Time to reach maximum (peak) blood and urine drug concentration (Tmax) and elimination half-life (t1/2) after single dose administration, Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed., 48 hours (period 1) , 1 hour (Period 2) | Secondary: Effect of timing of hemodialysis on the PK of aliskiren in End Stage Renal Disease (ESRD) patients, 48 hrs (Period 1), 1 hr (Period 2)|Number of patients with adverse events, serious adverse events and death, maximum 30 days
Sponsor/Collaborators: Sponsor: Novartis
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose:
Start Date: 2010-06
Completion Date: 2010-09
Results First Posted:
Last Update Posted: 2012-04-02
Locations: Charité Universitätsmedizin, Berlin, Germany
URL: https://clinicaltrials.gov/show/NCT01568775