Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Novartis

Status and phase: Completed; Phase 1

Conditions: Chronic Kidney Disease; Hypertension; Nephrotic Syndrome

Treatments: Drug: Valsartan (VAL489)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01447485

CVAL489K1101

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Valsartan 20 mg or 40 mg

Experimental group

Treatment:

Drug: Valsartan (VAL489)