Clinical Trial: A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertensive Patients
Brief Summary: Drugs used to treat high blood pressure in adults should also be effective in treating high blood pressure in children and adolescents. This study will test the safety and efficacy of valsartan in treating high blood pressure in hypertensive children 6-16 years of age whose parent(s)/guardian(s) grant permission to participate.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Change from baseline in sitting systolic blood pressure after 2 weeks
Original Primary Outcome:
Current Secondary Outcome:
- Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline diastolic blood pressure after 2 weeks
- Change in diastolic blood pressure after 2 weeks to 4 weeks
- Change from baseline diastolic blood pressure after 4 weeks
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 10, 2005
Date Started: December 2002
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016
