Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00379067
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2006-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Czechia', 'Denmark', 'Finland', 'France', 'Germany', 'Greece', 'Hungary', 'Ireland', 'Italy', 'Netherlands', 'Norway', 'Poland', 'Portugal', 'Russia', 'Spain', 'Switzerland', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}, {'id': 'D053158', 'term': 'Nocturia'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 882}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-08', 'studyFirstSubmitDate': '2006-09-19', 'studyFirstSubmitQcDate': '2006-09-19', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change from baseline to week 12 in mean number of nocturnal voids', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Benign Prostatic Hyperplasia', 'Nocturia', 'Actigraphy', 'Tamsulosin'], 'conditions': ['Benign Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg \\& placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed as having LUTS associated with BPH\n* On average, at least 2 voids per night over the last week\n* A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)\n\nExclusion Criteria:\n\n* Subject is currently taking diuretics\n* Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h'}, 'identificationModule': {'nctId': 'NCT00379067', 'briefTitle': 'A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Tamsulosin OCAS 0.4 mg Tablets, Once Daily on Nocturia, Compared to Placebo, in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': '617-EC-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Tamsulosin OCAS tablet', 'interventionNames': ['Drug: Tamsulosin OCAS']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin OCAS', 'type': 'DRUG', 'description': 'Adrenoceptor antagonist', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Europe Ltd.', 'class': 'INDUSTRY'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}