Overview

Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Valsartan
Criteria
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/exclusion criteria may apply