Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-31 @ 4:41 PM
Study NCT ID:
NCT01060969
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2008-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011654', 'term': 'Pulmonary Edema'}, {'id': 'D001929', 'term': 'Brain Edema'}, {'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000086', 'term': 'Acetazolamide'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-07', 'studyFirstSubmitDate': '2008-11-03', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results will be evaluated by using the Lake Louise AMS scoring system', 'timeFrame': 'one month after travel'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Mountain Sickness', 'travellers', 'Acetazolamide', 'Tadalafil', 'Acute Mountain Sickness assessed by Lake Louise score', 'High altitude pulmonary edema', 'High altitude cerebral edema'], 'conditions': ['Pulmonary Edema', 'Cerebral Edema']}, 'referencesModule': {'references': [{'pmid': '22943271', 'type': 'RESULT', 'citation': 'Leshem E, Caine Y, Rosenberg E, Maaravi Y, Hermesh H, Schwartz E. Tadalafil and acetazolamide versus acetazolamide for the prevention of severe high-altitude illness. J Travel Med. 2012 Sep-Oct;19(5):308-10. doi: 10.1111/j.1708-8305.2012.00636.x. Epub 2012 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.', 'detailedDescription': 'A randomized controlled study comparing:\n\nTadalafil \\[20mg x1/day\\] and acetazolamide \\[125mg x2 day\\], versus Acetazolamide \\[125mg x2 day\\] alone, in trekkers to altitude \\> 3,000 m.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in trekking to high altitude\n* Agreement to sign the informed consent.\n\nExclusion Criteria:\n\n* No agreement to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT01060969', 'briefTitle': 'Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention', 'orgStudyIdInfo': {'id': 'SHEBA-07-3977-ES-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetazolamide', 'description': 'acetazolamide 125 mg BID', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'EXPERIMENTAL', 'label': 'Acetazolamide and Tadalafil', 'description': 'Intervention arm', 'interventionNames': ['Drug: Tadalafil and acetazolamide']}], 'interventions': [{'name': 'Tadalafil and acetazolamide', 'type': 'DRUG', 'description': 'Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.', 'armGroupLabels': ['Acetazolamide and Tadalafil']}, {'name': 'Acetazolamide', 'type': 'DRUG', 'description': 'Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude', 'armGroupLabels': ['Acetazolamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Center of Geographic Medicine', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Ctr.', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Center for Travel and Geographic Medicine', 'investigatorFullName': 'Prof. Eli Schwartz MD, DTMH', 'investigatorAffiliation': 'Sheba Medical Center'}}}}