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Comparative Study of Valsartan and Amlodipine Versus Amlodipine Alone in Hypertension

Novartis · 2004
ClinicalTrials.gov · Datasets · License: Public Domain · 2004
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hypertension
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.
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