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A MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO CONTROLLED PROOF OF CONCEPT AND DOSE RANGING STUDY WITH AN ACTIVE CONTROL TO ASSESS THE EFFICACY AND SAFETY/TOLERABILITY OF UK-369,003...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-004378-28

A MULTI-CENTER, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO CONTROLLED PROOF OF CONCEPT AND DOSE RANGING STUDY WITH AN ACTIVE CONTROL TO ASSESS THE EFFICACY AND SAFETY/TOLERABILITY OF UK-369,003 IMMEDIATE RELEASE (IR) AND MODIFIED RELEASE (MR) IN THE TREATMENT OF MEN WITH LOWER URINARY TRACT SYMPTOMS (LUTS) WITH AND WITHOUT ERECTILE DYSFUNCTION (ED)

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Extrait

• Compare the efficacy of the 100mg modified release (MR) and 40mg immediate release (IR) formulations of UK-369,003 vs. placebo in men suffering from LUTS with and without ED. • Characterize the dose response relationship of the UK-369,003 modified release (MR) formulation in the treatment of men with LUTS with and without ED. • Investigate the efficacy of UK-369,003 MR doses relative to UK-369,003 40mg IR. • Investigate the efficacy of UK-369,003 MR doses relative to tamsulosin 0.4mg. • To evaluate the safety and tolerability of UK-369,003 in men with LUTS with and without ED.

Critère d'inclusion

  • Lower urinary tract symptoms (LUTS) in men with and without erectile dysfunction (ED)

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