A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171028
- Lead Sponsor
- Novartis
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT
- PARENTAL CONSENT MUST BE GRANTED
Exclusion Criteria
- BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS
Other protocol-defined exclusion criteria will apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline systolic blood pressure after 2 and 4 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸E. Hanover, New Jersey, United States