Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Male Patients With Lower Urinary Tract Syndrome

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 19, 2005
Last updated: October 18, 2007
Last verified: October 2007

The purpose of this study is to determine whether Tamusulosin is effective in the treatment of lower urinary tract syndrome with male patients.

Condition Intervention Phase
Urinary Tract Diseases
Drug: Tamusulosin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Further study details as provided by Astellas Pharma Inc:


Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with urination disorder not accompanied by apparent organic or neurologic abnormality(lower urinary tract syndrome: LUTs).

Exclusion Criteria:

  • Patients with urination disorder accompanied by apparent organic(benign prostatic hyperplasia: BPH) or neurologic abnormality, active urinary tract infections, severe cardiovascular, hepatic and/or kidney complications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00239317

Chubu region, Japan
Chugoku region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kinki region, Japan
Kyushu region, Japan
Touhoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Study Director Clinical Development, Astellas Pharma Inc.
  More Information

No publications provided Identifier: NCT00239317     History of Changes
Other Study ID Numbers: B617/LCT3
Study First Received: September 19, 2005
Last Updated: October 18, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
urinary tract diseases

Additional relevant MeSH terms:
Urologic Diseases processed this record on March 01, 2015