Hypertension
Conditions
Keywords
Hypertension,, Valsartan,, Hydrochlorothiazide
Brief summary
The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations. This study is being conducted in Japan.
Interventions
DRUGValsartan
DRUGHydrochlorothiazide
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Inclusion criteria
* Essential hypertension measured by mercury sphygmomanometer * Outpatients
Exclusion criteria
* Secondary hypertension or suspected of having secondary hypertension. * A history of malignant hypertension * Severe hypertension * Significant heart, renal, hepatic diseases or significant cerebrovascular disorder * Gout Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in diastolic blood pressure after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in systolic blood pressure after 8 weeks | — |
| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks | — |
| Change from baseline in standing diastolic blood pressure after 8 weeks | — |
| Change from baseline in standing systolic blood pressure after 8 weeks | — |
| Adverse events and serious adverse events at each study visit for 8 weeks | — |
Countries
Japan
Outcome results
None listed