Hypertension
Conditions
Keywords
Valsartan,, amlodipine,, hydrochlorothiazide
Brief summary
The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy. The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.
Interventions
DRUGvalsartan
DRUGamlodipine
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2
Exclusion criteria
Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg after 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks | — |
| Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks | — |
| Time when blood pressure reaches less than 140/90 mmHg | — |
| Change in blood pressure at baseline, week 4, 8, 11, and 14 | — |
| Adverse events and serious adverse events at each study visit for 14 weeks | — |
Countries
Germany, Switzerland
Outcome results
None listed