Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT00771394
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], '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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-13', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean number of urgency episodes per 24 hours', 'timeFrame': 'at 4, 8, 12 week'}], 'secondaryOutcomes': [{'measure': 'Mean number of micturitions per 24 hrs', 'timeFrame': 'at 4, 8, 12 week'}, {'measure': 'Mean number of incontinence episodes per 24 hours', 'timeFrame': 'at 4, 8, 12 week'}, {'measure': 'Mean number of micturitions per night', 'timeFrame': 'at 4, 8, 12 week'}, {'measure': 'Adverse Events, Laboratory Tests', 'timeFrame': 'end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vesicare', 'Solifenacin succinate', 'Tamsulosin', 'Overactive Bladder', 'BPH'], 'conditions': ['Benign Prostatic Hyperplasia', 'Benign Prostatic Hypertrophy', 'Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks', 'detailedDescription': 'Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks\n* Patients with urgency episodes and frequent micturitions\n* Written informed consent has been obtained\n* Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume \\< 50 mL\n\nExclusion Criteria:\n\n* Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)\n* Patients with obvious stress urinary incontinence\n* Patients with complications or who have a past history of a bladder tumor\n* Patients with urethral stricture or bladder neck stenosis\n* Patients with a history of surgery causing damage to the pelvic plexus\n* Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs\n* Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder"}, 'identificationModule': {'nctId': 'NCT00771394', 'briefTitle': 'Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride', 'orgStudyIdInfo': {'id': '905-JC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1. Tamsulosin alone', 'interventionNames': ['Drug: Tamsulosin hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': '2. Tamsulosin + solifenacin (low dose)', 'interventionNames': ['Drug: Tamsulosin hydrochloride', 'Drug: Solifenacin succinate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3. Tamsulosin + solifenacin (high dose)', 'interventionNames': ['Drug: Tamsulosin hydrochloride', 'Drug: Solifenacin succinate']}], 'interventions': [{'name': 'Tamsulosin hydrochloride', 'type': 'DRUG', 'otherNames': ['Harnal', 'YM617'], 'description': 'oral', 'armGroupLabels': ['1. Tamsulosin alone', '2. Tamsulosin + solifenacin (low dose)', '3. Tamsulosin + solifenacin (high dose)']}, {'name': 'Solifenacin succinate', 'type': 'DRUG', 'otherNames': ['Vesicare', 'YM905'], 'description': 'oral', 'armGroupLabels': ['2. Tamsulosin + solifenacin (low dose)', '3. Tamsulosin + solifenacin (high dose)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kantou', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}, {'city': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 44.62026, 'lon': 142.29986}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}