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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan
* Drug: Enalapril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valsartan 80 mg<br> | Drug: Valsartan<br>* Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.<br>|
| Experimental: Valsartan 160 mg<br> | Drug: Valsartan<br>* Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.<br>|
| Experimental: Valsartan 320 mg<br> | Drug: Valsartan<br>* Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.<br>|
| Active Comparator: Enalapril 10 mg<br> | Drug: Enalapril<br>* Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.<br>|
| Active Comparator: Enalapril 20 mg<br> | Drug: Enalapril<br>* Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.<br>|
| Active Comparator: Enalapril 40 mg<br> | Drug: Enalapril<br>* Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure. | Baseline and Week 12 | 
| Decrease in MSSBP to < 95th Percentile for Age, Gender and Height | The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12. | 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 | The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients. | Baseline and Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, pediatrics, High Blood Pressure, Hypertension, Valsartan, enalapril