Loading clinical trials...

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

An 8-day Open-label, Multiple-dose, Multicenter Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

NCT00834041•Novartis

View on ClinicalTrials.gov

Summary

This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 6-17 years of age
•Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
•Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
•Able to safely wash out previous antihypertensive therapy for 1-2 weeks

Exclusion Criteria

•Body weight of \< 21 kg (45 lbs) or \> 100 kg (220 lbs)
•Inability to discontinue prior antihypertensive medication as required during the washout period
•Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
•Renal artery stenosis
•Current diagnosis of heart failure (NYHA Class II-IV)
•msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
•Second or third degree heart block with or without a pacemaker
•Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
•Evidence of current symptomatic valvular disease

Locations (5)

Investigative Site

Louisville, Kentucky, United States

Investigative Site

Brussels, Belgium

Investigative Site

Brasília, Brazil

Investigative Site

Budapest, Hungary

Investigative Site

Warsaw, Poland

Key Dates

Start Date

April 1, 2009

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

May 9, 2011

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Aliskiren 3.125 mini-tablets

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

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

NCT07073820

Pulmonary Hypertension

View study

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: May 9, 2011Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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

Penn Medicine Healthy Heart

Preliminary Human Trials of F230 Tablets