A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171041
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
Inclusion Criteria
- CHILDREN HAVE SYSTOLIC BLOOD PRESSURE AT A LEVEL =>95th PERCENTILE FOR AGE/GENDER/HEIGHT
- CONSENT FROM PARENT(S)/GUARDIAN(S) MUST BE GRANTED
Exclusion Criteria
- BLOOD PESSURE IS =>5% HIGHER THAN 99th PERCENTILE FOR AGE
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON PHYSICAL EXAMINATION, AND LABORATORY AND OTHER ASSESSMENTS
Other protocol-defined inclusion/exclusion criteria will also apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in sitting systolic blood pressure after 2 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline diastolic blood pressure after 2 weeks Change from baseline systolic blood pressure after 4 weeks Change from baseline diastolic blood pressure after 4 weeks Change from baseline systolic and diastolic blood pressure after 4 weeks and 52 weeks Change in diastolic blood pressure after 2 weeks to 4 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸E.Hanover, New Jersey, United States