Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension
Phase 4
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00425997
- Lead Sponsor
- Novartis
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
- Male or female patients 18 years of age or older
- Diagnosed of having hypertension, defined as a mean seated systolic BP β₯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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method -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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Sites in USA
πΊπΈEast Hanover, New Jersey, United States
Sites in USAπΊπΈEast Hanover, New Jersey, United States