Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-24 @ 10:56 AM
Study NCT ID:
NCT02245503
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7391}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of information on concomitant diseases', 'timeFrame': 'day 1'}, {'measure': 'Collection of information on concomitant treatment', 'timeFrame': 'day 1'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse drug reactions', 'timeFrame': 'up to 6 months'}]}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The objectives of this post marketing surveillance study were to document the comorbidity and comedication during prescription of ALNA® (Tamsulosin) for patients with BPH (Benign Prostatic Hyperplasia).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with BPH recruited at urologist offices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for the treatment with ALNA according to its summary of product characteristics (SPC)\n\nExclusion Criteria:\n\n* Patients fulfilling one of the general or specific contraindications listed in the ALNA SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency cannot be included in the study'}, 'identificationModule': {'nctId': 'NCT02245503', 'briefTitle': 'Observational Study of ALNA® (Tamsulosin) in Patients With Benign Prostatic Hyperplasia (BPH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Comorbidity and Comedication During Prescription of ALNA® (Tamsulosin) for Patients With BPH (Benign Prostatic Hyperplasia)', 'orgStudyIdInfo': {'id': '527.40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Benign prostatic hyperplasia', 'description': 'Patients with symptomatic BPH to whom ALNA was prescribed', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['ALNA'], 'armGroupLabels': ['Benign prostatic hyperplasia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}