Official Title: “A Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: Valsartan
• Drug: Enalapril

Primary Measures

• Reduction of mean sitting systolic blood pressure (MSSBP) at Week 12 from baseline

Secondary Measures

• Reduction of mean sitting diastolic blood pressure (MSDBP) at Week 12 from baseline
• Decrease in MSSBP to < 95th percentile for age, gender and height at Week 12
• Change in mean ambulatory systolic blood pressure and mean ambulatory diastolic blood pressure over 24 hours in subset of patients, Week 12 compared to baseline
• Safety and tolerability of valsartan compared to enalapril

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Sponsor GmbH  

Overall Contact: Novartis Pharmaceuticals 862-778-8300 

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00433836

Study ID Number: CVAL489K2302

ClinicalTrials.gov Identifier: NCT00433836

Health Authority: United States: Food and Drug Administration