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...

Update Il y a 4 ans
Reference: EUCTR2007-004726-24

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

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Extract

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.


Inclusion criteria

  • essential hypertension