Overview

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

Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
Summary
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 ).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Valsartan
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 ≥ 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