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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01617681 | Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD | PHASE3 | COMPLETED | 127 | — | — | Nov 8, 2012 | Jan 24, 2017 | Sep 27, 2017 | 27 | Belgium, Brazil +7 |
Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase
| Arm | Type | Description |
|---|---|---|
| Valsartan 0.25 mg/kg | EXPERIMENTAL | Valsartan oral solution 0.25mg/kg once daily + matching placebo of valsartan oral solution 4 mg/kg once daily for 6 weeks (period 1) |
| Valsartan 4 mg/kg | EXPERIMENTAL | Valsartan oral solution 4 mg/kg once daily + matching placebo of valsartan oral solution 0.25 mg/kg once daily for 6 weeks (period 1) |
| Valsartan 1 mg/kg | EXPERIMENTAL | Open-label (Period 2) valsartan will be optionally titrated from 1 mg/kg to 2 mg/kg. Valsartan will continue to be optionally up titrated in 1 mg/kg increments every 4 weeks until maximum dose of 4 mg/kg is achieved. Duration 20 weeks. |
| Name | Type | Description |
|---|---|---|
| VAL489 | DRUG | Valsartan 3mg/kg oral solution |
| VAL489 matching placebo | DRUG | Valsartan 3 mg/kg oral solution |
Inclusion Criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: Have the ability to provide written informed consent; Have at baseline , a documented diagnosis of hypertension (as defined in the National High Blood Pressure Education Program 2004); ...