An 8-week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and amlodipine 10 mg compared to amlodipine 10 mg in patients with moderate to severe hypertension.

Trial Profile

An 8-week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and amlodipine 10 mg compared to amlodipine 10 mg in patients with moderate to severe hypertension.

Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2013

At a glance

  • Drugs Aliskiren/amlodipine (Primary) ; Amlodipine
  • Indications Hypertension
  • Focus Biomarker; Registrational; Therapeutic Use
  • Most Recent Events

    • 01 Sep 2012 Primary endpoint mean seated systolic blood pressure has been met according to results published in the International Journal of Clinical Practice.
    • 01 Sep 2012 Results published in the International Journal of Clinical Practice.
    • 27 Aug 2010 FDA approval of Tekamlo was based on clinical trial data involving more than 5000 patients, including data from this study, according to a Novartis media release.
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