Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-01 @ 8:47 AM
Study NCT ID:
NCT00668057
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2008-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069058', 'term': 'Vardenafil Dihydrochloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 624}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-05', 'studyFirstSubmitDate': '2008-04-24', 'studyFirstSubmitQcDate': '2008-04-27', 'lastUpdatePostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Global Assessment Questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Erectile Function domain score of the International Index of Erectile Function', 'timeFrame': '12 weeks'}, {'measure': 'Safety and tolerability', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Male Erectile Dysfunction'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.\n* Stable heterosexual relationship\n\nExclusion Criteria:\n\n* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)\n* Nitrate use\n* Other exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT00668057', 'briefTitle': 'BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction', 'orgStudyIdInfo': {'id': '10690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'interventionNames': ['Drug: Levitra (Vardenafil, BAY38-9456)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 4', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 5', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 6', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': '5 mg Vardenafil orally 1 hour prior to sexual intercourse', 'armGroupLabels': ['Arm 1']}, {'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': '10 mg Vardenafil orally 1 hour prior to sexual intercourse', 'armGroupLabels': ['Arm 2']}, {'name': 'Levitra (Vardenafil, BAY38-9456)', 'type': 'DRUG', 'description': '20 mg Vardenafil orally 1 hour prior to sexual intercourse', 'armGroupLabels': ['Arm 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '5 mg matching placebo', 'armGroupLabels': ['Arm 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '10 mg matching placebo', 'armGroupLabels': ['Arm 5']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '20 mg matching placebo', 'armGroupLabels': ['Arm 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100034', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100044', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100083', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100853', 'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}