Chronic Kidney Disease, Hypertension, Nephrotic Syndrome
Conditions
Keywords
Hypertension, chronic kidney disease, nephrotic syndrome, pharmacokinetics
Brief summary
This study will assess the pharmacokinetics and safety following single dose of valsartan in Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
Interventions
DRUGValsartan (VAL489)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome
Exclusion criteria
* GFR \< 30 mL/min/1.73 m2 * Inability to safely tolerate the temporary discontinuation of concomitant antihypertensive medications (expect amlodipine or atenolol) from 24 hours prior to study drug administration to study completion. * Inability to safely tolerate the temporary discontinuation of any drug known or suspected to effect hepatic or renal clearance capacity from 24 hours prior to study drug administration to study completion (this includes drugs that are known to cause induction or inhibition of hepatic enzymes). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CL/F of valsartan in plasma | Up to 24 hours post-dose |
| AUC of valsartan in plasma | Up to 24 hours post-dose |
| Cmax of valsartan in plasma | Up to 24 hours post-dose |
| Tmax of valsartan in plasma | Up to 24 hours post-dose |
| T1/2 of valsartan in plasma | Up to 24 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| ECG evaluations | 24 hours post-dose |
| Standard clinical laboratory evaluations | 24 hours post-dose |
| Vital signs | 2, 4, and 24 hours post-dose |
| Physical examination | 24 hours post-dose |
| Number and severity of adverse events | Up to 24 hours post-dose |
Countries
Japan
Outcome results
None listed