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Completed

NCT Number: NCT00379067

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Nocturia Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin OCAS

Drug

Adrenoceptor antagonist

Placebo

Drug

placebo

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Europe Ltd.
  • Boehringer Ingelheim

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 21, 2006
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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