Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Completed · Phase 3
Conditions studied: Hypertension
In brief
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 ).
Key facts
- Study ID
- NCT00435162
- Run by
- Novartis Pharmaceuticals
- People needed
- 74
- Starts
- 2007-03-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2011-05-09
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sites in USA — USA, New Jersey, United States
- Sites in Belgium — Belgium, Belgium
- Sites in Brazil — Brazil, Brazil
- Sites in France — Paris, France
- Sites in Hungary — Hungary, Hungary
- Sites in India — India, India
- sites in Italy — Italy, Italy
- Sites in Poland — Poland, Poland
- Sites in South Africa — South Africa, South Africa
- Sites in Sweden — Sweden, Sweden
- Sites in Turkey — Turkey, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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