drugset / Trial / NCT01485900
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAR407899A | Unknown | — | Oral |