Hypertension
Conditions
Keywords
hypertension, high blood pressure, valsartan/hydrochlorozide, severe hypertension
Brief summary
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Diagnosed severe hypertension
Exclusion criteria
* Inability to discontinue all prior antihypertensive medications * Heart failure of any kind * History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease * Diabetes with poor glucose control * Allergy to certain medications used to treat high blood pressure Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg after 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg after 6 weeks | — |
| Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks | — |
| Systolic blood pressure less than 140 mmHg after 4 and 6 weeks | — |
| Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks | — |
| Adverse events and serious adverse events at each study visit for 6 weeks | — |
Countries
United States
Outcome results
None listed