drugset / Trial / NCT01485900

Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment

NCT01485900 ↗

Phase 1 Completed 20 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: * To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease (CKD) on stable angiotensin converting enzyme-inhibitor (ACE-I) Secondary Objectives: * To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate * The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is (AcSDKP) * The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is

Timeline

Start
2011-11
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject SAR407899A Unknown — Oral