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.

Novartis Pharmaceuticals11 sites in 11 countries74 target enrollmentMarch 2007

ConditionsHypertension

InterventionsValsartan 0.25 mg/kg Valsartan 1.0 mg/kg Valsartan 4.0 mg/kg

DrugsValsartan 0.25 mg/kg Valsartan 1.0 mg/kg Valsartan 4.0 mg/kg

Overview

Phase: Phase 3
Intervention: Valsartan 0.25 mg/kg
Conditions: Hypertension
Sponsor: Novartis Pharmaceuticals
Enrollment: 74
Locations: 11
Primary Endpoint: Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 ).

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

January 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility 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

Arms & Interventions

Low Dose

Intervention: Valsartan 0.25 mg/kg

Medium Dose

Intervention: Valsartan 1.0 mg/kg

High Dose

Intervention: Valsartan 4.0 mg/kg

Outcomes

Primary Outcomes

Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)

Time Frame: baseline and week 6

Secondary Outcomes

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)