Hypertension
Conditions
Keywords
HYPERTENSION, VALSARTAN
Brief summary
SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301
Interventions
DRUGVALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
SUCCESSFUL COMPLETION OF STUDY CVAH631C2301 \-
Exclusion criteria
* NONE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and serious adverse events at each study visit for 54 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in diastolic blood pressure from baseline after 54 weeks | — |
| Change from baseline in systolic blood pressure from baseline after 54 weeks | — |
| Change from baseline in standing diastolic and systolic blood pressure after 54 weeks | — |
| Hematology and blood chemistries up to 54 weeks | — |
| Physical condition including pregnancy, pulse and weight at each study visit | — |
Countries
United States
Outcome results
None listed