Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Chronic Kidney Disease; Nephrotic Syndrome
• Intervention / Treatment: Drug: Valsartan (VAL489)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
    • Novartis Investigative Site
  • Tokyo, Japan
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CVAL489K1101 can be found on the Novartis Clinical Trial Results Website

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 6, 2011

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: pharmacokinetics; nephrotic syndrome; Hypertension, chronic kidney disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Urologic Diseases; Renal Insufficiency; Hypertension; Kidney Diseases; Renal Insufficiency, Chronic; Nephrotic Syndrome; Nephrosis; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan
• Other Study ID Numbers: CVAL489K1101