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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan (Drug); Enalapril (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


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).

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

Secondary outcome:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

Decrease in MSSBP to < 95th Percentile for Age, Gender and Height

Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients


Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.


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. Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

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 00000, Sweden

Sites in Turkey, Turkey, Turkey

Sites in USA, East Hanover, New Jersey 07936, United States

Additional Information

Starting date: January 2007
Last updated: April 19, 2011

Page last updated: August 23, 2015

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