Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-03 @ 8:15 AM
Study NCT ID:
NCT02244333
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4575}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, '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': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Change of Quality of Life (QoL) Index by means on patient questionnaire', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale', 'timeFrame': 'after 1 month'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in maximum urinary flow rate (Qmax)', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Change from Baseline in residual urinary volume', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Change from Baseline in blood pressure', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Change from Baseline in Pulse rate (bpm)', 'timeFrame': 'Baseline, after 1 month'}, {'measure': 'Change in complications due to low blood pressure', 'timeFrame': 'Baseline, after 1 month', 'description': 'Patient is asked for complications (weakness, dizziness, nausea)'}, {'measure': 'Global assessment of efficacy by investigator on 4-point scale', 'timeFrame': 'after 1 month'}, {'measure': 'Global assessment of tolerability by investigator on 4-point scale', 'timeFrame': 'after 1 month'}, {'measure': 'Global assessment with BPS- treatment by investigator on a 4-point scale', 'timeFrame': 'Baseline, after 1 month', 'description': 'Switch from Terazosin therapy to ALNA®'}]}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptomatic BPS, who switched for ALNA® after preceding Terazosin therapy recruited at urologists', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suffering from BPS symptoms\n* Preceding treating with Terazosin for at least one month\n* IPSS sum score \\>= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin\n* Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month\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 ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study'}, 'identificationModule': {'nctId': 'NCT02244333', 'briefTitle': 'Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'ALNA® - AWB in Pre-treated Patients With BPS', 'orgStudyIdInfo': {'id': '527.56'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with symptomatic BPS', 'interventionNames': ['Drug: ALNA®']}], 'interventions': [{'name': 'ALNA®', 'type': 'DRUG', 'armGroupLabels': ['Patients with symptomatic BPS']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}