Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-10 @ 6:13 AM
Study NCT ID:
NCT01736033
Status:
UNKNOWN
Last Update Posted:
2014-05-14
First Post:
2012-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}, {'id': 'D018120', 'term': 'Finasteride'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001378', 'term': 'Azasteroids'}, {'id': 'D013260', 'term': 'Steroids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 545}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2012-11-18', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Progression', 'timeFrame': '1 & 2 months after baseline, and then every 3 months up to 4 years', 'description': 'One of below\n\n* Deterioration of the symptoms\n* Acute urinary retention\n* Renal failure\n* Recurrent urinary tract infection\n* Urinary incontinence\n* Surgical procedure related to benign prostate hyperplasia'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score(IPSS)', 'timeFrame': '1 & 2 months after baseline, and then every 3 months up to 4 years'}, {'measure': 'International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form', 'timeFrame': 'every 6 months up to 4 years'}, {'measure': 'Uroflowmetry', 'timeFrame': 'every 6 months up to 4 years', 'description': 'including Qmax, voided volume and post-void residual volume(PVR)'}, {'measure': 'Prostate volume', 'timeFrame': 'every 1 year up to 4 years'}, {'measure': 'Global Response Assessment(GRA)', 'timeFrame': 'every 1 year up to 4 years'}, {'measure': 'PSA level', 'timeFrame': 'every 1 year up to 4 years', 'description': 'PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1\\~4 years, so there is possibilities that the blindedness is broken with the actual result.'}, {'measure': 'Blood Chemistry', 'timeFrame': 'every 1 year up to 4 years', 'description': 'including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin'}, {'measure': 'Adverse Events', 'timeFrame': 'every visit up to 4 years'}, {'measure': 'Physical examination', 'timeFrame': 'every 1 year up to 4 years', 'description': 'Digital Rectal Exam, Breast exam'}, {'measure': 'Male Sexual Health Questionnaire', 'timeFrame': 'every 6 months up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lower Urinary Tracts Symptoms', '5 alpha reductase inhibitor', 'Proscar', 'Finasteride', 'alpha blocker', 'Tamsulosin', 'Harnal D'], 'conditions': ['Benign Prostate Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '7539174', 'type': 'BACKGROUND', 'citation': 'Shapiro E, Lepor H. Pathophysiology of clinical benign prostatic hyperplasia. Urol Clin North Am. 1995 May;22(2):285-90.'}, {'pmid': '1714529', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7532234', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '2462301', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9117115', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.', 'detailedDescription': "Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.\n\nAs 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.\n\nTherefore, 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male patients aged over 50\n* Clinically diagnosed benign prostate hyperplasia(BPH)\n* 8 ≤ IPSS ≤ 30\n* 4 ml/sec ≤ Q max ≤ 15 ml/sec\n* minimum voided volume ≥ 125 ml\n* Post voided residual volume ≤ 250\n* Volunteer who singed on informed consent documents\n\nExclusion Criteria:\n\n* Past history of surgical procedure experience related to BPH\n* 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\n* Past history of taking alpha blocker within 2 weeks before screening\n* Past history of acute urinary retention within 3 months before screening\n* 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)\n* Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)\n* Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)\n* Unstable and significant medical condition including below\n\n * Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening\n * Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening\n * Medically uncontrollable diabetes mellitus, peptic ulcer disease\n * Severe hepatic diseases\n * Past history of renal failure or renal disease (serum creatinine \\> 1.4mg/dl)\n * Condition expected serious adverse event due to the investigational drug\n* Other conditions considered not eligible for the trial upon investigator's judgement"}, 'identificationModule': {'nctId': 'NCT01736033', 'acronym': 'ABSOLUTE', 'briefTitle': 'Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Clinical Study to Investigate the Efficacy and Safety of Treatment With Tamsulosin 0.2mg Mono and Tamsulosin 0.2mg, Finasteride 5mg Combination Therapy in Patients With LUTS/BPH', 'orgStudyIdInfo': {'id': 'TMS1011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Tamsulosin + Placebo', 'description': 'Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression', 'interventionNames': ['Drug: Tamsulosin', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin + Finasteride', 'description': 'Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression', 'interventionNames': ['Drug: Tamsulosin', 'Drug: Finasteride']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['Harnal D (brand name in Asia)', 'Flomax'], 'description': '1 tablet(0.2mg) orally q.d.', 'armGroupLabels': ['Tamsulosin + Finasteride', 'Tamsulosin + Placebo']}, {'name': 'Finasteride', 'type': 'DRUG', 'otherNames': ['Proscar'], 'description': '1 tablet(5mg) orally q.d.', 'armGroupLabels': ['Tamsulosin + Finasteride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet(0.2mg) orally q.d.', 'armGroupLabels': ['Tamsulosin + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheonan', 'state': 'Chungcheongnam-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'city': 'Anyang', 'state': 'Gyeoggi', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 36.9577, 'lon': 127.1464}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': "Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital Bucheon', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'city': 'Hwasun', 'state': 'Jeollanam-do', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital', 'geoPoint': {'lat': 35.06125, 'lon': 126.98746}}, {'city': 'Cheongju-si', 'state': 'North Chungcheong', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Eulji General Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Soo Woong Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Korea, Inc.', 'class': 'INDUSTRY'}, {'name': 'Medical Research Collaborating Center, Seoul, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Soo Woong Kim, MD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}