Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VAL489 · 1 trial · 1 indication
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); ...
VAL489 is an investigational small molecule being studied for the treatment of pediatric hypertension with or without chronic kidney disease (CKD). It is being developed by Novartis AG (NVS) and is currently in Phase 3 clinical development, though the single completed trial means it remains investigational and not yet approved.
VAL489 is a small molecule developed by Novartis AG (NVS) for pediatric hypertension with or without CKD. The specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here.
VAL489 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is an investigational small molecule in Phase 3 development for pediatric hypertension with or without chronic kidney disease.
VAL489 is in Phase 3 clinical development. It is an investigational small molecule being studied for pediatric hypertension with or without CKD. The single Phase 3 trial has been completed, but the drug is not yet approved and remains under clinical investigation by Novartis AG (NVS).
VAL489 has one completed Phase 3 clinical trial, NCT01617681, titled 'Efficacy, Safety and Tolerability of Multiple Doses of Valsartan in Children With Hypertension With or Without CKD.' The randomized, double-blind, controlled trial enrolled 127 participants aged 1 year and older across nine countries, including Belgium, Brazil, France, Germany, Guatemala, Hungary, Italy, Lithuania, and Poland.
VAL489 is being studied in a clinical trial that evaluates valsartan, and the trial title references valsartan as the active substance. However, the available information does not explicitly state that VAL489 is an alternative name for valsartan, so the relationship between the two names is not confirmed.