Clinical trial NCT00435162: Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Children
pediatrics
High Blood Pressure
Hypertension
Valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-14
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 ).


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

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Period 1 (Week 6)
timeFrame: baseline and week 6
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)to End of Period 1 (Week 6)
timeFrame: baseline and week 6
measure: Change From End of Period 1 (Week 6) in Mean Sitting Systolic Blood Pressure (MSSBP) to End of Placebo-controlled Withdrawal Period (Week 8)
timeFrame: week 6 and week 8
measure: Change From End of Period 1 (Week 6) in Mean Sitting Diastolic Blood Pressure (MSDBP) to End of Placebo-controlled Withdrawal Period (Week 8)
timeFrame: week 6 and week 8
Other outcomes:
Locations:
city: USA
country: United States
facility: Sites in USA
state: New Jersey
city: Belgium
country: Belgium
facility: Sites in Belgium
city: Brazil
country: Brazil
facility: Sites in Brazil
city: Paris
country: France
facility: Sites in France
city: Hungary
country: Hungary
facility: Sites in Hungary
city: India
country: India
facility: Sites in India
city: Italy
country: Italy
facility: sites in Italy
city: Poland
country: Poland
facility: Sites in Poland
city: South Africa
country: South Africa
facility: Sites in South Africa
city: Sweden
country: Sweden
facility: Sites in Sweden
city: Turkey
country: Turkey
facility: Sites in Turkey
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: