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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00239317
First received: September 19, 2005
Last updated: October 18, 2007
Last verified: October 2007
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239317

Locations
Japan
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
Investigators
Study Director: Study Director Clinical Development, Astellas Pharma Inc.
  More Information

No publications provided

ClinicalTrials.gov 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:
tamsulosin
urinary tract diseases
male

Additional relevant MeSH terms:
Urologic Diseases
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013