Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00150358
Status:
COMPLETED
Last Update Posted:
2021-02-01
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED.'}], 'secondaryOutcomes': [{'measure': 'The evaluation of change from baseline to week 8 on the toal SHI-M (Sexual Health Inventory-Male) score and the 5 individual items on the SHI-M. Global Efficacy Assessment Questions 2 and 3 at week 8.'}]}, 'conditionsModule': {'conditions': ['Impotence', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with arterial hypertension treated with one or more antihypertensive agents, the doses of which have been stable for at least 4 weeks prior to the baseline visit, with a documented clinical diagnosis of ED and a confirmation of this by a qualification of 21 or less on the SHI-M.\n\nExclusion Criteria:\n\n* Subjects with resting sitting systolic blood pressure \\>170 or \\<110mmHg or resting sitting diastolic blood pressure \\>90 or \\<50mmHg, with significant cardiovascular disease and retinitis pigmentosa, treatment with nitrates, alfablockers or CYP3A4 inhibitors.'}, 'identificationModule': {'nctId': 'NCT00150358', 'briefTitle': 'To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open Label, Multicenter, Non Comparative Study, To Confirm The Efficacy And Tolerability Of Viagra In Subjects With Erectile Dysfunction And Arterial Hypertension Who Are Taking Antihypertensive Treatment.', 'orgStudyIdInfo': {'id': 'A1481187'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72000', 'city': 'Torreón', 'state': 'Coahuila', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.54389, 'lon': -103.41898}}, {'zip': '44290', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '06090', 'city': 'Colonia Centro', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '06760', 'city': 'DF', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '07760', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64000', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '78240', 'city': 'San Luis PotosÃ-', 'state': 'San Luis PotosÃ-', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '97070', 'city': 'Mérida', 'state': 'Yucatán', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 20.967, 'lon': -89.62318}}, {'zip': 'C.P. 20230', 'city': 'Aguascalientes', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 21.88262, 'lon': -102.2843}}, {'zip': '31238', 'city': 'Chihuahua City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '34300', 'city': 'Durango', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 24.02032, 'lon': -104.65756}}, {'zip': '52140', 'city': 'Metepec', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.25934, 'lon': -99.60175}}, {'zip': '72090', 'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '78090', 'city': 'San Luis Potosí City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 22.15234, 'lon': -100.97135}}, {'zip': 'C.P. 97897', 'city': 'Veracruz', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 19.18095, 'lon': -96.1429}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}