Hypertension
Conditions
Keywords
HCTZ, hypertension, valsartan, amlodipine
Brief summary
This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ
Interventions
DRUGvalsartan
DRUGhydrochlorothiazide
DRUGamlodipine
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 patients ≥18 years of age * Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2 * Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1
Exclusion criteria
* Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure. * MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2. * Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma. * Known Keith-Wagener grade III or IV hypertensive retinopathy. * Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks. | — |
| Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks. | — |
| Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks | — |
| Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks | — |
Countries
Switzerland
Outcome results
None listed