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

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Silodosin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01259531

CWP-SDS-403

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.