Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-07 @ 6:38 PM
Study NCT ID:
NCT01273259
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2011-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-08', 'studyFirstSubmitDate': '2011-01-07', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of DHEA on exercise capacity (six-minute walk test)', 'timeFrame': 'inclusion and one year of treatment'}], 'secondaryOutcomes': [{'measure': 'Pulmonary and systemic arterial pressures (mean, systolic and diastolic)', 'timeFrame': 'Inclusion and after one year of treatment'}, {'measure': 'Pulmonary vascular resistances', 'timeFrame': 'Inclusion and after one year of treatment'}, {'measure': 'Safety / Compliance', 'timeFrame': 'along one year of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension, pulmonary', 'DHEA', 'six-minute walk test', 'pulmonary arterial pressure'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Hypertension, Pulmonary']}, 'descriptionModule': {'briefSummary': 'DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old and ≤ 75 years old\n* Chronic Obstructive Pulmonary Disease with FEVs/VC \\< 70% (\\*)\n* Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (\\*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)\n* PO2 ≤ 70 mmHg assessed by arterial gasometry at ease\n* If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening\n* Written informed consent\n\n(\\*) Criteria assessed from last health check or the last exams for COPD diagnosis\n\nExclusion Criteria:\n\n* clinical instability and/or respiratory exacerbation dangerous for catheterization\n* Pregnancy (ßHCG \\> 20 UI /l) or breastfeeding on going\n* General corticotherapy \\> 0,5 mg/kg/day prednisolon equivalent\n* Hepatic insufficiency (TP \\< 50%) or renal insufficiency (creatininemia \\> 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)\n* Left-heart failure (coronary heart disease and/or left valvulopathy)\n* High level of prostatic specific antigen (PSA) (\\> 7ng/ml)\n* Cancer antecedent or treatment on going'}, 'identificationModule': {'nctId': 'NCT01273259', 'briefTitle': 'Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial', 'orgStudyIdInfo': {'id': 'CHUBX 2003/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '200 mg /day arm', 'interventionNames': ['Drug: DHEA Treatment']}, {'type': 'EXPERIMENTAL', 'label': '25 mg/day arm', 'interventionNames': ['Drug: DHEA Treatment']}], 'interventions': [{'name': 'DHEA Treatment', 'type': 'DRUG', 'description': 'DHEA : 200 mg/day hard gelatine capsule', 'armGroupLabels': ['200 mg /day arm']}, {'name': 'DHEA Treatment', 'type': 'DRUG', 'description': 'DHEA : 25 mg/day hard gelatine capsule', 'armGroupLabels': ['25 mg/day arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital, Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jean-Pierre LEROY / Clinical Research and Innovation Director', 'oldOrganization': 'University Hospital, Bordeaux'}}}}