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

Novartis Pharmaceuticals11 sites in 11 countries300 target enrollmentJanuary 2007

ConditionsHypertension

InterventionsValsartan Enalapril

DrugsValsartan Enalapril

Overview

Phase: Phase 3
Intervention: Valsartan
Conditions: Hypertension
Sponsor: Novartis Pharmaceuticals
Enrollment: 300
Locations: 11
Primary Endpoint: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

January 2007

End Date

February 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility Criteria

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

Arms & Interventions

Valsartan 80 mg

Intervention: Valsartan

Valsartan 160 mg

Intervention: Valsartan

Valsartan 320 mg

Intervention: Valsartan

Enalapril 10 mg

Intervention: Enalapril

Enalapril 20 mg

Intervention: Enalapril

Enalapril 40 mg

Intervention: Enalapril

Outcomes

Primary Outcomes

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

Time Frame: Baseline and Week 12

Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.

Secondary Outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline and Week 12)
Decrease in MSSBP to < 95th Percentile for Age, Gender and Height(at week 12)
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients(Baseline and Week 8)