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Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

NCT ID: NCT01447485

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Hypertension Chronic Kidney Disease Nephrotic Syndrome

Keywords

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Hypertension, chronic kidney disease nephrotic syndrome pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Valsartan 20 mg or 40 mg

Group Type EXPERIMENTAL

Valsartan (VAL489)

Intervention Type DRUG

Interventions

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Valsartan (VAL489)

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Aichi, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6883

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

Other Identifiers

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CVAL489K1101

Identifier Type: -

Identifier Source: org_study_id