An eight-week, randomized, double-blind, parallel group, multicenter, dose escalation study to evaluate the efficacy and safety of aliskiren administered alone and in combination with ramipril in pati...

Update Il y a 5 ans
Reference: EUCTR2004-001062-40

An eight-week, randomized, double-blind, parallel group, multicenter, dose escalation study to evaluate the efficacy and safety of aliskiren administered alone and in combination with ramipril in patients with hypertension and diabetes mellitus

Woman and Man

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Extract

The primary objectives of this study are to: • Demonstrate the efficacy of the combination of aliskiren 300 mg and ramipril 10 mg in patients with hypertension and diabetes mellitus by testing the hypothesis of superior reduction in MSDBP from baseline when compared to the component monotherapies. • Compare the efficacy of aliskiren 300 mg to ramipril 10 mg in patients with hypertension and diabetes mellitus by testing the hypothesis that aliskiren monotherapy is non-inferior (or superior) to ramipril 10 mg in MSDBP reduction from baseline.


Inclusion criteria

  • Hypertension with diabetes mellitus