A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.

Inclusion Criteria:

• Diagnosed as having LUTS associated with BPH
• On average, at least 2 voids per night over the last week
• A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

Exclusion Criteria:

• Subject is currently taking diuretics
• Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h