Status:
COMPLETED
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypertension
Eligibility:
All Genders
6-5 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00435162
Start Date
March 1 2007
End Date
January 1 2009
Last Update
May 9 2011
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Sites in USA
USA, New Jersey, United States
2
Sites in Belgium
Belgium, Belgium
3
Sites in Brazil
Brazil, Brazil
4
Sites in France
Paris, France