Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01447485

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Chronic Kidney Disease Nephrotic Syndrome	Drug: Valsartan (VAL489)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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 Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valsartan 20 mg or 40 mg	Drug: Valsartan (VAL489)

Arm

Intervention/Treatment

Experimental: Valsartan 20 mg or 40 mg

Drug: Valsartan (VAL489)

Outcome Measures

Primary Outcome Measures

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]
CL/F of valsartan in plasma [Up to 24 hours post-dose]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts 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