Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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