Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01485900 | Repeated Dosing Study to Assess Safety and Tolerability in CKD-3 Patients on Stable ACE-I Treatment | PHASE1 | COMPLETED | 20 | — | — | Nov 1, 2011 | Aug 1, 2012 | Aug 23, 2012 | 2 | Moldova, Romania |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo |
| Cohort 2 | EXPERIMENTAL | Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo |
| Name | Type | Description |
|---|---|---|
| SAR407899A | DRUG | Pharmaceutical form:capsule Route of administration: oral |
Inclusion criteria: * Male and female patients aged between 18 and 79 * Patients with chronic kidney disease (CKD-3) * Patients should be on stable ACE-I treatment (same type and regimen) for at least 2 months prior to screening * Body weight between 50.0 kg and 115.0 kg inclusive if male, between ...