Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Phase 1

Completed

• Conditions: Hypertension; Chronic Kidney Disease; Nephrotic Syndrome
• Interventions: Drug: Valsartan (VAL489)

• Registration Number: NCT01447485
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-31
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-06
• Status Verified: 2012-05
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valsartan 20 mg or 40 mg	Valsartan (VAL489)	-

Primary Outcome Measures

Name	Time	Method
AUC 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
Cmax of valsartan in plasma	Up to 24 hours post-dose
Tmax of valsartan in plasma	Up to 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
ECG evaluations	24 hours post-dose
Physical examination	24 hours post-dose
Number and severity of adverse events	Up to 24 hours post-dose
Standard clinical laboratory evaluations	24 hours post-dose
Vital signs	2, 4, and 24 hours post-dose

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokyo, Japan