Hypertension Clinical Trial
Official title:
A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
The objective of this study is to evaluate efficacy, safety and tolerability of the
valsartan+amlodipine association in patients with mild to moderate essential hypertension,
in comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO
classification (8)]. The diastolic blood pressure threshold for inclusion in this study is
95 mmHg, as these patients are more likely to benefit from association therapy than patients
with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will
not be included in this study. Moreover, patients developing severe hypertension (MSDBP >
110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued
from the study.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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