Evaluation of long-term safety and tolerability in children 6 to 17 years of age who have high blood pressure.

• Conditions: Hypertension.; MedDRA version: 14.0Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.0Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 14.0Level: LLTClassification code 10005747Term: Blood pressure highSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-017594-37-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-22
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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.;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.