Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-22 @ 4:35 AM
Study NCT ID:
NCT00347061
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2006-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2006-06-30', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One year safety data of SL77.0499-10'}], 'secondaryOutcomes': [{'measure': 'One year efficacy data and plasma concentration of SL77.0499-10'}]}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasiam', 'Adrenergic alpha-antagonist'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Primary:\n\nTo assess the safety of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.\n\nSecondary:\n\n* To provide the information on the efficacy of SL77.0499-10 10mg administered once daily for one year in patients with lower urinary tract symptoms related to BPH.\n* To document the plasma concentration of SL77.0499-10 after repeated administration of SL77.0499-10 10mg administered once daily in patients with lower urinary tract symptoms related to BPH.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a symptomatic BPH diagnosed clinically by digital rectal examination and ultrasonography\n* Suffering for at least 6 months from lower urinary tract symptoms related to BPH\n* An I-PSS total score ≥ 13\n* Out patient\n\nExclusion Criteria:\n\n* Patients previously treated with SL77.0499-10.\n* Neurogenic bladder dysfunction, confirmed or suspected, irrespective of aetiology.\n* Isolated bladder neck disease.\n* Diagnosed carcinoma of the prostate.\n* Previous prostatic surgery or other invasive procedures (thermotherapy…) for the treatment of BPH.\n* Patients having an indwelling catheter.\n* A residual urine \\> 200mL.\n* Patients with Moderate or sever hepatic insufficiency.\n* Known hypersensitivity to alpha1-blockers.\n* Patients who have received anti-androgens, 5alpha-reductase inhibitors, LH-RH analogues within the previous 3 months before Screening\n* Patients judged inappropriate for admission to the study by the Investigator or the Sub-Investigator.'}, 'identificationModule': {'nctId': 'NCT00347061', 'briefTitle': 'Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Long-term Safety and Efficacy of SL77.0499-10 10mg Once-daily Tablets in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia (BPH).A Multicenter, 52-week, Open Label, Uncontrolled Study.', 'orgStudyIdInfo': {'id': 'LTS5235'}}, 'armsInterventionsModule': {'interventions': [{'name': 'afuzosin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}