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A Randomized, Eight Week Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy.

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Trial Profile

A Randomized, Eight Week Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Aliskiren/amlodipine (Primary) ; Amlodipine
  • Indications Essential hypertension
  • Focus Adverse reactions; Biomarker; Registrational

Most Recent Events

  • 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.
  • 21 Oct 2009 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
  • 21 Oct 2009 Actual patient number (849) added as reported by ClinicalTrials.gov.

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