A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
Phase 4
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Drug: Placebo
- Registration Number
- NCT00379067
- Lead Sponsor
- Astellas Pharma Inc
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 882
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tamsulosin OCAS Tamsulosin OCAS tablet 2 Placebo Placebo tablet
- Primary Outcome Measures
Name Time Method The change from baseline to week 12 in mean number of nocturnal voids 12 weeks
- Secondary Outcome Measures
Name Time Method The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void 12 weeks