Completed
PHASE1
INTERVENTIONAL
NCT01485900
Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Detailed Description
The total duration for this study will be around 8 weeks.
Interventions
Name:
SAR407899A
Type:
DRUG
Description:
Pharmaceutical form:capsule
Route of administration: oral
Primary Outcomes
Measure:
Number of patients reporting Adverse Events (AEs)
TimeFrame:
8 weeks
Description:
Trial Information
NCT ID
NCT01485900
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Sanofi
Last Updated
December 15, 2025