Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)
NCT ID: NCT01259531
Last Updated: 2012-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2010-12-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Silodosin
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
Silodosin
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
Interventions
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Silodosin
Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
50 Years
MALE
No
Sponsors
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Chonnam National University Hospital
OTHER
Kangdong Sacred Heart Hospital
OTHER
Yeungnam University Hospital
OTHER
Pusan National University Hospital
OTHER
Seoul National University Hospital
OTHER
Samsung Medical Center
OTHER
Seoul St. Mary's Hospital
OTHER
Korea University Guro Hospital
OTHER
Chonbuk National University Hospital
OTHER
Asan Medical Center
OTHER
JW Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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G.S. Park, Prof
Role: STUDY_CHAIR
Chonnam National Univ.
D.Y. Yang, Prof
Role: PRINCIPAL_INVESTIGATOR
Kangdong Sacred Heart
K.H. Moon, Prof
Role: PRINCIPAL_INVESTIGATOR
Yeongnam Univ. Medical
N.C. Park
Role: PRINCIPAL_INVESTIGATOR
Pusan National Univ. Hospital
S.W. Kim, Prof
Role: PRINCIPAL_INVESTIGATOR
Seoul National Univ. Hospital
S.W. Lee, Prof
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
S.W. Kim, Prof
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital
D.G. Moon, Prof
Role: PRINCIPAL_INVESTIGATOR
Korea Univ. Guro Hospital
J.K. Park, Prof
Role: PRINCIPAL_INVESTIGATOR
Chunbuk National Univ. Hospital
T.Y. Ahn, Prof
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Seoul national university hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CWP-SDS-403
Identifier Type: -
Identifier Source: org_study_id