An open label extension study to evaluate safety, tolerability, and efficacy of 18 weeks of valsartan treatment in children 1-5 years old with hypertension. - ND

• Conditions: hypertension; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2006-005473-21-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. Patients who qualified and entered core study CVAL489K2303. 2. Patients who participated in the core study CVAL489K2303, completed period 1 and were re-randomized in period 2 and continued for at least 3 days in period 2.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who did not complete period 1 of the core study. 2. Patients who were re-randomized in period 2 of core study but did not continue for >=3 days in period 2 of the core study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified