Official Title: “A 14 Week Extension to a Randomized, Double-Blind, Multicenter, Parallel-Group, Active-Controlled Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan and Enalapril Combined and Alone in Children 6 to 17 Years of Age With Hypertension”

The purpose of this extension study is to evaluate in children the long-term (up to 6 months total) safety and tolerability of valsartan in comparison with enalapril. In addition it will evaluate proteinuria reduction, renopreservation, and tolerability of valsartan and enalapril combination vs. enalapril monotherapy alone in patients with chronic kidney disease.

Study Type: Interventional

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

Study Primary Completion Date: September 2010

Intervention(s) in this Clinical Trial

• Drug: Valsartan, enalapril

Primary Measures

• Long-term safety and tolerability of valsartan and enalapril alone or in combination in children aged 6-17 years old with hypertension

Secondary Measures

• Evaluate the percentage of non-Chronic Kidney Disease (CKD) patients treated with valsartan or enalapril alone with a Mean sitting Systolic Blood Pressure < 95th percentile for gender, age and height from baseline to week 26 (responder).
• Evaluate the mean seated systolic blood pressure reduction in non-CKD patients treated with valsartan or enalapril alone from baseline to week 26 (BP reduction).
• Evaluate the mean ambulatory blood pressure reduction for all patients (participating in ABPM) from baseline to week 26 as measured by 24 hour ABPM.
• Evaluate the percentage of CKD patients treated with valsartan and enalapril combination or enalapril monotherapy achieving urine protein/creatinine ratio (UPCR) reduction by ≥ 25% from week 12 to week 26
• Evaluate the percentage of CKD patients on valsartan and enalapril combination vs. enalapril monotherapy who have urine protein/creatinine ratio (UPCR) reduced by ≥ 50% from baseline to week 26

Inclusion Criteria:

• Successful completion of 12 weeks of double blind treatment in core protocol
• CVAL489K2302.
• Patients participating in study CVAL489K2302 who may have discontinued prematurely due to uncontrolled hypertension defined as; MSSBP >20%, but <25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.

Exclusion Criteria:

• Renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV).
• 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 and AV block controlled with a pacemaker
• 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 Chair Sponsor GmbH  

Overall Contact: Novartis (US) Pharmaceuticals 862-778-8300 

Information obtained from ClinicalTrials.gov on August 27, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446511

Study ID Number: CVAL489K2302E1

ClinicalTrials.gov Identifier: NCT00446511

Health Authority: United States: Food and Drug Administration