Phase 3 Completed N=74 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT00435162 ↗

Enrolled (actual)

Serious AEs

5.4%

Results posted

May 2011

Primary outcomePrimary: Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6) — -8.3; -10.3; -14.4 mm Hg — p=0.0990

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 ).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)	-8.3; -10.3; -14.4	0.0990
SECONDARY Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)	-4.7; -8.6; -6.7	—
SECONDARY Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)	2.6; 4.1	—
SECONDARY Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)	1.8; 3.4	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00435162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.