Hypertension
Conditions
Keywords
hypertension, valsartan, amlodipine, HCTZ
Brief summary
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).
Exclusion criteria
* Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1. * Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1. * Patients on four or more antihypertensive drugs at Visit 1. * Arm circumference \> 42 cm for patients participating in ABPM. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline diastolic blood pressure after 8 weeks | — |
| Change from baseline systolic blood pressure after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks | — |
| Blood pressure less than 140/90 mmHg after 8 weeks | — |
| Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks | — |
| Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements | — |
| Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks | — |
Countries
United States
Outcome results
None listed