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A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipi...

Mise à jour : Il y a 5 ans
Référence : EUCTR2006-004586-34

A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone

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Extrait

To confirm that the combination of valsartan/amlodipine 160/5mg is non-inferior to amlodipine 10mg alone when comparing the reduction of MSSBP from baseline to week 8 (Visit 4) between the two treatment groups. To confirm that the combination of valsartan/amlodipine 160/5mg induces less peripheral edema compared to amlodipine 10mg alone up to Visit 4 (week 8) quantified as adverse event (AE) reported peripheral edema.

Critère d'inclusion

  • Hypertension

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