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

A multicenter, open-label 18 month study to evaluate the long-term safety and tolerability of valsartan in children 6 to 17 years of age with hypertension and with or without chronic kidney disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017594-37-DE

Enrollment

150

Registered

2011-04-28

Start date

2011-06-29

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension.

Interventions

Trade Name: Diovan 40 mg Product Name: Diovan Product Code: VAL489 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VALSARTAN CAS Number: 137862-53-4 Current Sponsor code: VAL489 Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1) AST/ALT > 3xULN 2) Bilirubin > 2xULN 3) eGFR < 30ml/min/1.73m2 4) Patients using RAAS blockers after screening

Design outcomes

Primary

Measure	Time frame
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.;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.	—

Measure

Time frame

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.;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.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Blood pressure reduction 2) Blood pressure control 3) Proteinuria and eGFR reduction;Timepoint(s) of evaluation of this end point: Week 78/Endpoint.	—

Countries

Colombia, Finland, Germany, Guatemala, India, Korea, Republic of, Philippines, Poland, Romania, Russian Federation, Singapore

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com004901802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026