Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT00730418
Status:
COMPLETED
Last Update Posted:
2010-08-26
First Post:
2008-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
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': 'D017292', 'term': 'Doxazosin'}], 'ancestors': [{'id': 'D011224', 'term': 'Prazosin'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-25', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of alpha-1 adrenoceptor', 'timeFrame': 'before treatment and 12mos and 24 mos after treatment'}], 'secondaryOutcomes': [{'measure': 'International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events', 'timeFrame': 'before treatment and 3mos, 12mos, and 24mos after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasia', 'alpha Adrenergic Blockers', 'alpha-1 Adrenergic Receptor'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)', 'detailedDescription': 'To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as\n\n* Real-time RT-PCR\n* Radioligand receptor binding\n* Western blot\n* Immunohistochemistry'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 50 yrs or greater\n* International prostatic symptom score \\>= 8\n* Maximal flow rate \\< 15mL/sec\n* baseline PSA 2.5-10 ng/mL\n* Pathologically proven BPH\n* No medication history for BPH\n* Able to give fully informed consent\n\nExclusion Criteria:\n\n* Previous use of alpha-blocker, 5-alpha reductase inhibitor\n* Previous surgery for BPH\n* Urologic cancer history\n* Urethral stricture\n* baseline PSA \\> 10ng/mL\n* BP \\< 90/70 mmHg\n* Orthotopic hypotension with syncope\n* Serum Cr \\> 2.0 mg/dl, alanine aminotransferase \\> 1.5 times of normal limit\n* Bacterial prostatitis within 1 year\n* Urinary tract infection(UTI) more than 2 times within 1 year\n* Active UTI or prostate biopsy within 1 month\n* Unable to void\n* Ped use because of incontinence\n* Hypersensitivity to alpha-blocker that include quinazoline\n* Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months\n* Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)\n* Psychiatric problem\n* Alcohol abuse or other drug abuse history\n* Severe comorbidities unable to perform long-term trial\n* seems not to be appropriate to this study because of any other reasons"}, 'identificationModule': {'nctId': 'NCT00730418', 'briefTitle': 'Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '2006-08-118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'doxazosin 4mg', 'description': 'doxazosin 4mg group', 'interventionNames': ['Drug: Doxazosin']}, {'type': 'EXPERIMENTAL', 'label': 'doxazosin 8mg', 'description': 'doxazosin 8mg group', 'interventionNames': ['Drug: Doxazosin']}], 'interventions': [{'name': 'Doxazosin', 'type': 'DRUG', 'otherNames': ['Cadura XL 4mg'], 'description': 'Treatment with doxazosin 4mg daily for 24 mos', 'armGroupLabels': ['doxazosin 4mg']}, {'name': 'Doxazosin', 'type': 'DRUG', 'otherNames': ['Cadura XL 8mg'], 'description': 'Treatment with doxazosin 8mg daily for 24 mos', 'armGroupLabels': ['doxazosin 8mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kru-Sung Lee, Ph.D., M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyu-Sung Lee/Professor', 'oldOrganization': 'Samsung Medical Center'}}}}