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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Valsartan 4.0 mg/kg; Drug: Valsartan 1.0 mg/kg; Drug: Valsartan 0.25 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435162

CVAL489K2303

Details and patient eligibility

About

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 ).

Enrollment: 74 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 3 patient groups

Low Dose

Experimental group

Treatment:

Drug: Valsartan 0.25 mg/kg

Medium Dose

Experimental group

Treatment:

Drug: Valsartan 1.0 mg/kg

High Dose

Experimental group

Treatment:

Drug: Valsartan 4.0 mg/kg