EUCTR2006-005408-14-ITActive, not recruitingNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- OVARTIS FARMA
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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