Loading clinical trials...

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

A Multicenter, Open-label, 18 Month Study to Evaluate the Long-term Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age With Hypertension and With or Without Chronic Kidney Disease

NCT01365481•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the long-term safety and tolerability profile of valsartan and valsartan-based treatments in children with hypertension, with or without chronic kidney disease.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of hypertension
•able to swallow a tablet
•body weight ≥18 kg and ≤160 kg at baseline
•MSSBP must be ≥ 95th percentile and ≤25% above the 95th percentile for age, gender and height.

Exclusion Criteria

•Any clinically significant physical abnormalities or clinically relevant abnormal laboratory values (other than those relating to renal function) obtained at the screening visit. Including the following:
•1. AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range. Patients known to have active or chronic hepatitis were excluded.
•2. Total bilirubin \>2 times the upper limit of the reference range
•3. Estimated GFR \<30 mL/min/1.73m² (calculated using Modified Schwartz Formula)
•4. WBC count \<3000/mm³
•5. Platelet count \<100,000/mm³
•6. Serum potassium \>5.3 mmol/L
•7. Hemoglobin \<8 g/dL
•Uncontrolled diabetes mellitus
•Unilateral, bilateral and graft renal artery stenosis
+13 more criteria

Locations (28)

Novartis Investigative Site

Bucaramanga, Santander Department, Colombia

Novartis Investigative Site

Barranquilla, Colombia

Novartis Investigative Site

Cali, Colombia

Novartis Investigative Site

Helsinki, Finland, Finland

Novartis Investigative Site

Bochum, Germany

Novartis Investigative Site

Cottbus, Germany

Novartis Investigative Site

Freiburg im Breisgau, Germany

Novartis Investigative Site

Homburg, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Guatemala City, Departamento de Guatemala, Guatemala

Key Dates

Start Date

August 1, 2011

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

July 13, 2016

Enrollment

150

ACTUAL participants

Conditions

HypertensionChronic Kidney Disease

Interventions

Valsartan

DRUG

amlodipine

DRUG

Hydrochlorothiazide

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

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

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: July 13, 2016Data 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

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

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

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed 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

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication