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Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension

NCT00433836•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, ages 6-17, with a documented history of hypertension
•Must be able to swallow a pill
•Must be ≥ 18 kg or ≤160 kg
•MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement
•Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)

Exclusion Criteria

•Renal artery stenosis
•Current diagnosis of heart failure (NYHA Class II-IV).
•MSSBP ≥ 25% above the 95th percentile
•Second or third degree heart block without a pacemaker.
•Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
•Clinically significant valvular heart disease.
•Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy.
•Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.

Locations (11)

Sites in USA

East Hanover, New Jersey, United States

Sites in Belgium

Sites in Belgium, Belgium

Sites in France

Sites in France, France

Sites in Germany

Sites in Germany, Germany

Sites in Hungary

Hungary, Hungary

Sites in India

Sites in India, India

Sites in Italy

Sites in Italy, Italy

Sites in Poland

Poland, Poland

Sites in Slovakia

Slovakia, Slovakia

Sites in Sweden

Sites in Sweden, Sweden

Key Dates

Start Date

January 1, 2007

Primary Completion Date

February 1, 2009

Completion Date

February 1, 2009

Last Updated

May 19, 2011

Enrollment

300

ACTUAL participants

Conditions

Hypertension

Interventions

Valsartan

DRUG

Enalapril

DRUG

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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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: May 19, 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

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

Inclusion Criteria

Exclusion Criteria

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