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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Europe Ltd.; Boehringer Ingelheim
• Treatments: Tamsulosin

Criteria

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