Clinical Trial: A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
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 Hypertension P
Brief Summary: Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children. This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.
Detailed Summary:
Sponsor: Novartis
Current Primary Outcome: Change from baseline systolic blood pressure after 2 and 4 weeks
Original Primary Outcome:
Current Secondary Outcome:
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline diastolic blood pressure after 2 weeks
- Change in 2 week diastolic blood pressure after 2 more weeks
- Change in baseline diastolic blood pressure after 4 weeks
- Adverse events, serious adverse events, and laboratory values during 4 weeks
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: September 10, 2005
Date Started: December 2003
Date Completion:
Last Updated: November 7, 2011
Last Verified: June 2006
