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

Astellas

Status and phase: Completed; Phase 4

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tamsulosin OCAS; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00379067

617-EC-006

Details and patient eligibility

About

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.

Enrollment: 882 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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882 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Tamsulosin OCAS tablet

Treatment:

Drug: Tamsulosin OCAS

2

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo