A 14 week extension to a randomized, double-blind, multicenter, parallel-group, active-controlled study to evaluate the long term safety, tolerability and efficacy of valsartan and enalapril combined and alone in children 6 to 17 years of age with hypertension - ND

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

• Registration Number: EUCTR2006-005408-14-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: 300

Inclusion Criteria

Please refer to the CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study. Additional inclusion criteria: Successful completion of 12 weeks of double blind treatment in core protocol CVAL489K2302. Discontinuing prematurely from the core CVAL489K2302 study due to uncontrolled hypertension defined as; MSSBP >20%, but <25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Please refer to the CVAL489K2302 for complete details related to the inclusion and exclusion criteria for the core study. Additional exclusion criteria: Patients who experienced any adverse events considered serious and drug related in protocol CVAL489K2302 are excluded.

Study & Design

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