Hypertension
Conditions
Keywords
Hypertension, High blood pressure, Blood pressure control, Blood pressure reduction, Valsartan
Brief summary
This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male or female age 18 or older * Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and \<110 mm Hg)
Exclusion criteria
* Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg * History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.) * History of myocardial infarction, stroke \[e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)\], or onset of heart failure within the last 6 months. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline systolic blood pressure after 4 weeks | — |
| Change from baseline systolic blood pressure after 2 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period | — |
| Blood pressure less than 140/90 mmHg after 6 weeks | — |
| Change from baseline diastolic blood pressure after 6 weeks | — |
| Change from baseline in blood and urine markers after 6 weeks | — |
Countries
United States
Outcome results
None listed