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Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure - NCT00435162-(Clinical Trial 162667)



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City:  Charleston
State:  
WV
Zip Code:
Conditions: Hypertension
Purpose: 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 ).
Study summary:
Criteria: 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 ≥ 8 kg or ≤ 40 kg at randomization - Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile, 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 - Creatinine clearance < 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
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Data Source: ClinicalTrials.gov
Date Processed: February 1, 2010
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