Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Summary

This clinical study is designed to evaluate the efficacy and safety of silodosin in a 12 week treatment of patients with severe urinary disorders associated with benign prostatic hyperplasia (BPH).

Conditions

• Benign Prostatic Hyperplasia

Interventions

DRUG

Silodosin

Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.

Sponsors & Collaborators

• Chonnam National University Hospital

  collaborator OTHER

• Kangdong Sacred Heart Hospital

  collaborator OTHER

• Yeungnam University Hospital

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Chonbuk National University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• JW Pharmaceutical

  lead INDUSTRY

Principal Investigators

• G.S. Park, Prof · Chonnam National Univ.

• D.Y. Yang, Prof · Kangdong Sacred Heart

• K.H. Moon, Prof · Yeongnam Univ. Medical

• N.C. Park · Pusan National Univ. Hospital

• S.W. Kim, Prof · Seoul National Univ. Hospital

• S.W. Lee, Prof · Samsung Medical Center

• S.W. Kim, Prof · Seoul St. Mary's Hospital

• D.G. Moon, Prof · Korea Univ. Guro Hospital

• J.K. Park, Prof · Chunbuk National Univ. Hospital

• T.Y. Ahn, Prof · Asan Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

50 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-12-31

Primary Completion

2011-09-30

Completion

2011-09-30

Countries

• South Korea

Study Locations