An open-label, randomized, parallel group study comparing the efficacy and safety of Amlodipine in combination with Valsartan compared to Losartan in combination with Hydrochlorothiazide given for 52 ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-001977-17

An open-label, randomized, parallel group study comparing the efficacy and safety of Amlodipine in combination with Valsartan compared to Losartan in combination with Hydrochlorothiazide given for 52 weeks on the regression of left ventricular hypertrophy in patients with mild-to-moderate hypertension

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Extrait

To demonstrate a noninferior or superior efficacy of the combination of valsartan 160mg and amlodipine 5mg compared with the combination of losartan 100mg and HCTZ 12.5mg by testing the hypothesis that the regression of LVH, as measured by the change in LVMI [g/m2] via MRI from baseline to end of study is at least irrelevantly smaller or even larger under valsartan/amlodipine compared to losartan/HCTZ in patients with mild-to moderate hypertension and LVH.


Critère d'inclusion

  • patients with mild-to-moderate hypertension and left ventricular hypertrophy

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