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Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01447485•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 14 years

Sex

ALL

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).

Locations (2)

Novartis Investigative Site

Aichi, Japan

Novartis Investigative Site

Tokyo, Japan

Key Dates

Start Date

August 1, 2011

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

December 21, 2020

Enrollment

ACTUAL participants

Conditions

HypertensionChronic Kidney DiseaseNephrotic Syndrome

Interventions

Valsartan (VAL489)

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication