Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 2:07 PM
Study NCT ID:
NCT00599235
Status:
COMPLETED
Last Update Posted:
2010-04-08
First Post:
2008-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil and Exercise Capacity in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D006830', 'term': 'Hydralazine'}], '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'}, {'id': 'D010793', 'term': 'Phthalazines'}, {'id': 'D011724', 'term': 'Pyridazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-07', 'studyFirstSubmitDate': '2008-01-07', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak oxygen uptake (VO2) during exercise', 'timeFrame': '1 week of treatment'}], 'secondaryOutcomes': [{'measure': 'Exercise systolic blood pressure', 'timeFrame': 'Maximal exercise'}, {'measure': 'Pulse wave velocity and pulse wave analysis', 'timeFrame': 'Before and after maximal exercise'}]}, 'conditionsModule': {'keywords': ['Hypertension', 'Exercise capacity', 'PDE5 inhibitors'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Hypertension (persistently elevated blood pressure) is a major risk factor for heart disease and stroke. Hypertensive individuals show a reduced exercise capacity, which is present from a very early stage and contributes to their increased cardiovascular risk. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it works by enhancing the effects of nitric oxide, a substance that dilates blood vessels and increases blood flow. We hypothesize that sildenafil, because of its effect on nitric oxide and blood flow, will improve exercise capacity in hypertensive patients. Therefore, the main aim of the study is to investigate the effects of PDE5 inhibition on exercise capacity and vascular function in hypertension, and to compare these effects in hypertensive patients and healthy controls.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male (age range: 18 - 70 years)\n* Appropriate blood pressure range\n* Hypertensive - Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg\n* Controls - Systolic BP \\<140 mmHg and diastolic BP \\<90mmHg\n* Written informed consent\n\nExclusion Criteria:\n\n* Female\n* History of coronary artery, cerebrovascular or peripheral vascular disease within the last 6 months\n* Total cholesterol \\>6.5 mmol/L\n* Current alcohol abuse\n* Diabetes mellitus\n* Asthma\n* Taking any anti-hypertensive, vasoactive or endothelial function modifying drugs which cannot be withdrawn for the purpose of the study\n* ECG evidence of clinically significant arrhythmia or cardiac ischaemia\n* Clinically significant abnormality on screening blood test\n* Contraindication to strenuous exercise\n* Current involvement in other research projects\n* Other clinically relevant conditions\n* Lack of written informed consent'}, 'identificationModule': {'nctId': 'NCT00599235', 'briefTitle': 'Sildenafil and Exercise Capacity in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Effects of the Selective Phosphodiesterase Type 5 Inhibitor Sildenafil Citrate on Exercise Capacity and Vascular Function in Hypertensive Subjects', 'orgStudyIdInfo': {'id': 'LREC/2004/4/13'}, 'secondaryIdInfos': [{'id': 'LREC/2004/4/13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: sildenafil', 'Drug: hydralazine', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: sildenafil', 'Drug: hydralazine', 'Drug: placebo']}], 'interventions': [{'name': 'sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': '50mg 3 times daily for 7 days', 'armGroupLabels': ['1', '2']}, {'name': 'hydralazine', 'type': 'DRUG', 'description': '25mg 3 times daily for 7 days', 'armGroupLabels': ['1', '2']}, {'name': 'placebo', 'type': 'DRUG', 'description': '3 times daily for 7 days', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh - Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Teresa M Attinà, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Edinburgh'}, {'name': 'David J Webb, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marise Bucukoglu', 'oldOrganization': 'University of Edinburgh'}}}}