Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 9:47 PM
Study NCT ID:
NCT02972268
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2016-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D000069464', 'term': 'Solifenacin Succinate'}], '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': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 780}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-22', 'lastUpdatePostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of TUFS', 'timeFrame': '12 weeks from baseline'}, {'measure': 'change of total IPSS', 'timeFrame': '12 weeks from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lower Urinary Tract Symptoms', 'Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy with Tamsulosin Monotherapy for Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 45 years\n* Benign Prostate Hyperplasia diagnosed by 20 mL \\< TRUS\n* Lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form\n\nExclusion Criteria:\n\n* Subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 3 years\n* Subjects who have acute urinary retention within 12 weeks before screening\n* Subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 24 weeks before screening\n* Subjects who have hypersensitivity to investigational product\n* Subjects who were suspected or confirmed neurogenic bladder, bladder neck structure, bladder diverticulum\n* Subjects who have myasthenia gravis, narrow angle glaucoma\n* Subjects who have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n* SBP \\> 180 mmHg or DBP \\> 100 mmHg\n* HbA1c \\> 9.0 %\n* Subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.'}, 'identificationModule': {'nctId': 'NCT02972268', 'briefTitle': 'Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Compare the Efficacy and Safety of Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'JLP-1207-P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'Tamsulosin 0.2mg + Solifenacin 5mg', 'interventionNames': ['Drug: Tamsulosin 0.2mg + Solifenacin 5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group II', 'description': 'Tamsulosin 0.2mg + Placebo(Solifenacin)', 'interventionNames': ['Drug: Tamsulosin 0.2mg + Placebo(Solifenacin)']}], 'interventions': [{'name': 'Tamsulosin 0.2mg + Solifenacin 5mg', 'type': 'DRUG', 'description': 'Tamsulosin 0.2mg + Solifenacin 5mg for 12wks', 'armGroupLabels': ['Group I']}, {'name': 'Tamsulosin 0.2mg + Placebo(Solifenacin)', 'type': 'DRUG', 'description': 'Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Myung Soo Choo, MD., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}