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

Astellas Pharma Inc882 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

882

Conditions

Benign Prostatic Hyperplasia

Interventions

Tamsulosin OCASDRUG

Adrenoceptor antagonist

PlaceboDRUG

placebo

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The change from baseline to week 12 in mean number of nocturnal voids

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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