Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 10:52 PM
Study NCT ID:
NCT00730067
Status:
WITHDRAWN
Last Update Posted:
2012-08-23
First Post:
2008-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006973', 'term': 'Hypertension'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'As a single center, it was not possible to recruit enough patients with pulmonary hypertension', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2008-08-04', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walk test', 'timeFrame': 'at base line, after 2 hours and after 3 months'}], 'secondaryOutcomes': [{'measure': 'assessment of life quality', 'timeFrame': 'At baseline and follow up after three months'}, {'measure': 'Systolic pulmonary pressure', 'timeFrame': 'At baseline and follow-up after three months'}, {'measure': 'Activity of symptoms measured by use of short acting beta agonists', 'timeFrame': 'At baseline and follow-up after three months'}, {'measure': 'Levels of NT-proBNP and apelin', 'timeFrame': 'At baseline and follow-up after three months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Pulmonary hypertension', 'Sildenafil', 'NT-pro BNP', 'apelin'], 'conditions': ['COPD', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the increased pulmonary blood pressure betters the patients symptoms.\n\nIn this study 32 patients with increased pulmonary blood pressure due to COPD will be randomized to 3 months treatment with placebo or sildenafil, which is known to lower the pulmonary blood pressure in other types of pulmonary hypertension.\n\nOur hypothesis is that treatment with sildenafil in these patients will improve the functional capacity measured by the distance walked in 6 minutes and life quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.\n* A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.\n* Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.\n* Age \\> 18\n* Informed written consent.\n* Reliable anticonception for fertile women.\n\nExclusion Criteria:\n\n* Rheumatic disease limiting walking capacity.\n* Exacerbation in COPD during the study.\n* Age\\>80 years\n* FEV1 \\< 25 % of predicted.\n* Allergy towards contents of sildenafil or placebo tablets.\n* Fall in blood pressure of \\> 30 mmHg systolic or \\>20 mmHg diastolic after intake of the first dose of trial medication.\n* Fall in peripheral saturation of \\> 5% after intake of the first dose of trial medication.\n* Treatment with nitrous vasodilators or aminophyllamines.'}, 'identificationModule': {'nctId': 'NCT00730067', 'briefTitle': 'Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Sildenafil for COPD-associated Pulmonary Hypertension. A Randomized Double Blinded Placebo Controlled Study.', 'orgStudyIdInfo': {'id': '2008-002237-73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Sildenafil treatment', 'interventionNames': ['Drug: sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'sildenafil', 'type': 'DRUG', 'otherNames': ['Viagra'], 'description': 'Sildenafil 50 mg three times daily', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'tablet with Laetose mono hydrat, talc,Potato tarch, Gelatin, Magnesium stearate.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Dk-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Pulmonary Diseases, Århus Sygehus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': 'DK_8200', 'city': 'Århus N', 'country': 'Denmark', 'facility': 'Department of Cardiology, Skejby sygehus'}], 'overallOfficials': [{'name': 'Ole Hilberg, MDSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Århus Sygehus'}, {'name': 'Jens Erik Nielsen-Kudsk, MDSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skejby Sygehus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Charlotte Andersen', 'investigatorAffiliation': 'University of Aarhus'}}}}