Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure [SSBP] ≥ 95th percentile ).

Official Title
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A Randomized, Multicenter, Double-blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period.

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan 0.25 mg/kg
* Drug: Valsartan 1.0 mg/kg
* Drug: Valsartan 4.0 mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension Must be able to swallow liquid formulation Must be ≥ 6 kg or ≤ 40 kg at randomization Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language Exclusion Criteria: Patients with background ARB therapy Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function) AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range Glomerular filtration rate < 30 mL/min/1.73m² Serum potassium > upper limit of the reference range MSSBP ≥ 25% above the 95th percentile Patients exhibiting clinically significant ECG abnormalities Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 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: Low Dose<br> | Drug: Valsartan 0.25 mg/kg<br>* once daily<br>|
| Experimental: Medium Dose<br> | Drug: Valsartan 1.0 mg/kg<br>* once daily<br>|
| Experimental: High Dose<br> | Drug: Valsartan 4.0 mg/kg<br>* once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6) |  | baseline and week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6) |  | baseline and week 6 | 
| Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8) |  | week 6 and week 8 | 
| Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8) |  | week 6 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