Hypertension
Conditions
Keywords
Hypertension, valsartan/HCTZ, amlodipine and HCTZ
Brief summary
This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood pressure monitoring (ABPM)
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
Healthy volunteers
No
Inclusion criteria
* Male or female patients 18 years of age or older * Diagnosed of having hypertension, defined as a mean seated systolic BP ≥160 mmHg (Stage 2 hypertension)
Exclusion criteria
* Symptomatic or severe hypertension * Patients treated with more than 2 antihypertensive medications * Clinically known or suspected history of secondary hypertension * Myocardial infarction, stroke, transient ischemic attack, cardiovascular revascularization/angioplasty in last 6 months * Diagnosis of heart failure (NYHA Class II-IV) * Chronic renal or severe hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Change from baseline in mean 24-hr ambulatory systolic blood pressure (BP) after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ | — |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline in mean 24-hr ambulatory diastolic BP and pulse pressure after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ | — |
| Change from baseline in mean seated systolic and diastolic BP after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ | — |
| Compare the proportion of patients achieving blood pressure goal and tolerability after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ | — |
Countries
United States
Outcome results
None listed