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

 -  Is at least 50 years old

 -  Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or
 higher

 -  Has a QoL score of 3 or higher

 -  Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec

 -  Has a PRV of below 100mL

 -  Voluntarily decides to participate in this trial and sign with informed consent form

 Exclusion Criteria:

 -  Has been administered silodosin

 -  Has been administered an α1A-adrenoceptor blocker within one month

 -  Has been prescribed antiandrogens except 5α-reductase inhibitors within a year

 -  Has had phytotherapy within 3 months

 -  Has had prostatectomy

 -  Has had intrapelvic radiation therapy

 -  Has had transurethral microwave hyperthermia of transurethral needle ablation

 -  Is suspected to have implications that are likely to affect urine passing such as
 neurogenic bladder, bladder calculus or active urinary tract infection (UTI).

 -  Is conducting self-catherterization

 -  Has a renal impairment with a serum creatinine of 2.0mg/dL or greater

 -  Has severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) or
 has a total bilirubin of 2.5mg/dl or higher or has AST/ALT 2.5 times higher than the
 normal (upper) level

 -  Has suffered from a severe arrhythmia, cardiac failure, cardiac infarction, unstable
 angina, cerebral infarction within 6 months

 -  Has experienced allergy to α1 receptor blockers

 -  Has orthostatic hypotension around the time of Screening Visit

 -  Has participated in other clinical trials within 8 weeks prior to Screening Visit

 -  Has a Prostate specific antigen(PSA) of higher 10ng/mL or has been diagnosed with
 tumor identified by a biopsy even though he has a PSA of lower 10ng/mL (Patient who
 has been administered 5α-reductase inhibitors for more than 3 months are presumed to
 have 2 times higher than their actual PSA levels)

 -  Has been taking unstable dosing of 5α-reductase inhibitors like finasteride or
 dutasteride for the past 3 months or is expected to change the dosage during the
 trial.