Evaluation of long-term safety and tolerability in children 6 to 17 years of age who have high blood pressure.
- Conditions
- Hypertension.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-017594-37-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
Inclusion Criteria
6 - 17 years with MSSBP>/= 95th percentile for age, gender and height.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1) AST/ALT > 3xULN
2) Bilirubin > 2xULN
3) eGFR < 30ml/min/1.73m2
4) Patients using RAAS blockers after screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety and tolerability profile of valsartan and valsartan based treatments in children with hypertension, with or without chronic kidney disease.;Secondary Objective: Assees long-term efficacy in reducing MSSBP and MSDBP; Assess long-term efficacy in controlling MSSBP and MSDBP; Assess the effect of valsartan on proteinuria and eGFR in CKD patients.;Primary end point(s): Long-term safety and tolerability of valsartan in children with hypertension with and without chronic kidney disease.;Timepoint(s) of evaluation of this end point: Safety data during the 18 month tretament period for the safety population.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Blood pressure reduction<br>2) Blood pressure control<br>3) Proteinuria and eGFR reduction;Timepoint(s) of evaluation of this end point: Week 78/Endpoint.