Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
NCT ID: NCT01736033
Last Updated: 2014-05-14
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
545 participants
INTERVENTIONAL
2012-02-29
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH
NCT00510406
Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients
NCT02244229
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
NCT02972268
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
NCT05236634
Effects of Alpha Blockers on Prostate-specific Antigen (PSA) Change in Men With Lower Urinary Tract Symptoms (LUTS)
NCT01250483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.
Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tamsulosin + Placebo
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
Tamsulosin
1 tablet(0.2mg) orally q.d.
Placebo
1 tablet(0.2mg) orally q.d.
Tamsulosin + Finasteride
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
Tamsulosin
1 tablet(0.2mg) orally q.d.
Finasteride
1 tablet(5mg) orally q.d.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tamsulosin
1 tablet(0.2mg) orally q.d.
Finasteride
1 tablet(5mg) orally q.d.
Placebo
1 tablet(0.2mg) orally q.d.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinically diagnosed benign prostate hyperplasia(BPH)
* 8 ≤ IPSS ≤ 30
* 4 ml/sec ≤ Q max ≤ 15 ml/sec
* minimum voided volume ≥ 125 ml
* Post voided residual volume ≤ 250
* Volunteer who singed on informed consent documents
Exclusion Criteria
* Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
* Past history of taking alpha blocker within 2 weeks before screening
* Past history of acute urinary retention within 3 months before screening
* Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA \< 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
* Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
* Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
* Unstable and significant medical condition including below
* Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
* Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
* Medically uncontrollable diabetes mellitus, peptic ulcer disease
* Severe hepatic diseases
* Past history of renal failure or renal disease (serum creatinine \> 1.4mg/dl)
* Condition expected serious adverse event due to the investigational drug
* Other conditions considered not eligible for the trial upon investigator's judgement
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma Korea, Inc.
INDUSTRY
Medical Research Collaborating Center, Seoul, Korea
OTHER
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Soo Woong Kim, MD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Soo Woong Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea
Hallym University Sacred Heart Hospital
Anyang, Gyeoggi, South Korea
Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Pusan National University Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Eulji General Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Shapiro E, Lepor H. Pathophysiology of clinical benign prostatic hyperplasia. Urol Clin North Am. 1995 May;22(2):285-90.
Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
Bosch JL, Kranse R, van Mastrigt R, Schroder FH. Reasons for the weak correlation between prostate volume and urethral resistance parameters in patients with prostatism. J Urol. 1995 Mar;153(3 Pt 1):689-93. doi: 10.1097/00005392-199503000-00039.
Chung TG, Chung J, Lee MS, Ahn H. Prevalence of benign prostatic hyperplasia in Jeong-Eup Area: community-based study. Korean J Urol 1999;40:52-8.
The prevalence of benign prostatic hyperplasia in elderly men in Korea: a community-based study. Park HK, Park H, Cho S, Bae J, Jeong S, Hong SK, et al. Korean J Urol 2009;50:843-7.
Lepor H, Gup DI, Baumann M, Shapiro E. Laboratory assessment of terazosin and alpha-1 blockade in prostatic hyperplasia. Urology. 1988 Dec;32(6 Suppl):21-6.
Noble AJ, Chess-Williams R, Couldwell C, Furukawa K, Uchyiuma T, Korstanje C, Chapple CR. The effects of tamsulosin, a high affinity antagonist at functional alpha 1A- and alpha 1D-adrenoceptor subtypes. Br J Pharmacol. 1997 Jan;120(2):231-8. doi: 10.1038/sj.bjp.0700907.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TMS1011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.