Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Condition(s) targeted: Hypertension; Chronic Kidney Disease; Nephrotic Syndrome

Intervention: Valsartan (VAL489) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Official title: A Multicenter, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Valsartan in Japanese Pediatric Patients 6 to 14 Years of Age

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

AUC of valsartan in plasma

Cmax of valsartan in plasma

Tmax of valsartan in plasma

T1/2 of valsartan in plasma

CL/F of valsartan in plasma

Secondary outcome:

ECG evaluations

Standard clinical laboratory evaluations

Vital signs

Physical examination

Number and severity of adverse events

Minimum age: 6 Years. Maximum age: 14 Years. Gender(s): Both.

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

Novartis Investigative Site, Aichi, Japan

Novartis Investigative Site, Tokyo, Japan

Starting date: August 2011
Last updated: May 6, 2012