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A twenty six-week, randomized, double-blind, parallel group, multicenter, active controlled, dose titration study to evaluate the efficacy and safety of aliskiren compared to HCTZ with the optional ad...

Mise à jour : Il y a 5 ans
Référence : EUCTR2004-004015-38

A twenty six-week, randomized, double-blind, parallel group, multicenter, active controlled, dose titration study to evaluate the efficacy and safety of aliskiren compared to HCTZ with the optional addition of amlodipine, followed by a second twenty six weeks of blinded treatment in patients with essential hypertension

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Extrait

Compare the long term efficacy of an aliskiren based treatment regimen (aliskiren 150 mg, 300 mg with optional add-on of amlodipine 5 mg/10 mg) to a HCTZ based treatment regimen (HCTZ 12.5 mg, 25 mg with optional add-on of amlodipine 5 mg/10 mg), in patients with essential hypertension by (i) testing the hypothesis of non-inferiority of the aliskiren regimen versus the HCTZ regimen on reduction of Mean Sitting Diastolic Blood Pressure (MSDBP) from baseline at 26 weeks, and (ii) the hypothesis of superiority for the aliskiren regimen versus the HCTZ regimen on reduction in MSDBP from baseline, if the hypothesis of non-inferiority is achieved

Critère d'inclusion

  • Hypertension

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