Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-01-31

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 ).

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Low Dose

Group Type EXPERIMENTAL

Valsartan 0.25 mg/kg

Intervention Type DRUG

once daily

Medium Dose

Group Type EXPERIMENTAL

Valsartan 1.0 mg/kg

Intervention Type DRUG

once daily

High Dose

Group Type EXPERIMENTAL

Valsartan 4.0 mg/kg

Intervention Type DRUG

once daily

Interventions

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Valsartan 0.25 mg/kg

once daily

Intervention Type DRUG

Valsartan 1.0 mg/kg

once daily

Intervention Type DRUG

Valsartan 4.0 mg/kg

once daily

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No