A multicenter, double-blind, randomized, parallel-group study to evaluate the safety, tolerability, and efficacy of once daily amlodipine/valsartan 5/80mg as compared to amlodipine/valsartan 5/40mg or to amlodipine 5mg once daily in elderly patients with essential hypertension not adequately controlled after four weeks on amlodipine 5mg once daily
The primary objective of this trial is to evaluate the overall safety and tolerability profile of a regimen of amlodipine/valsartan 5/80 mg as compared to a regimen of amlodipine/valsartan 5/40 mg (with optional titration to amlodipine/valsartan 5/80 mg) after 8 weeks of treatment in elderly patients with essential hypertension not adequately controlled after four weeks on amlodipine 5 mg monotherapy. The intent of this study is to demonstrate that the safety profiles of the two amlodipine/valsartan regimens (5/80 mg and 5/40 mg optionally titrated to 5/80 mg) are comparable in elderly patients with essential hypertension.