Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT01902758
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2013-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Combination on Exercise Performance at High Altitude
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C467894', 'term': 'ambrisentan'}, {'id': 'D013806', 'term': 'Theophylline'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'brent.ruby@mso.umt.edu', 'phone': '406-243-2117', 'title': 'Director of the Montana Center for Work Physiology and Exercise Metabolism', 'organization': 'University of Montana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ambrisentan and Theophylline', 'description': 'ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days\n\nambrisentan and theophylline', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group\n\nplacebo: placebo for comparison group', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time (Minutes) to Complete 2 Miles on a Treadmill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ambrisentan and Theophylline', 'description': 'ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days\n\nambrisentan and theophylline'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group\n\nplacebo: placebo for comparison group'}], 'classes': [{'categories': [{'measurements': [{'value': '1544', 'spread': '109', 'groupId': 'OG000'}, {'value': '1540', 'spread': '158', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'after arriving at high altitude (within 1 hour)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ambrisentan and Theophylline', 'description': 'ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days\n\nambrisentan and theophylline'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group\n\nplacebo: placebo for comparison group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ambrisentan and Theophylline', 'description': 'ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days\n\nambrisentan and theophylline'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group\n\nplacebo: placebo for comparison group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '2', 'groupId': 'BG000'}, {'value': '23', 'spread': '2', 'groupId': 'BG001'}, {'value': '23', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2013-07-11', 'resultsFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-16', 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (Minutes) to Complete 2 Miles on a Treadmill', 'timeFrame': 'after arriving at high altitude (within 1 hour)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['exercise performance'], 'conditions': ['Acute Mountain Sickness']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to determine the effectiveness of using two FDA approved medications in concert to reduce the likelihood of sickness due to low oxygen levels and to reduce the decrement in physical performance at higher elevations. The investigators hypothesize that this drug combination will reduce the symptoms of acute mountain sickness and improve exercise performance at high altitude compared to placebo.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males\n\nExclusion Criteria:\n\n* VO2max below 45ml/kg/min\n* currently taking any medication'}, 'identificationModule': {'nctId': 'NCT01902758', 'briefTitle': 'Drug Combination on Exercise Performance at High Altitude', 'organization': {'class': 'OTHER', 'fullName': 'University of Montana'}, 'officialTitle': 'Enhancing Physical Performance and Mitigating Acute Mountain Sickness Via Pharmaceutical Intervention While at Altitude', 'orgStudyIdInfo': {'id': 'UM82-13'}, 'secondaryIdInfos': [{'id': 'N66001-10-C-2134', 'type': 'OTHER_GRANT', 'domain': 'DARPA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ambrisentan and theophylline', 'description': 'ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days', 'interventionNames': ['Drug: ambrisentan and theophylline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ambrisentan and theophylline', 'type': 'DRUG', 'armGroupLabels': ['ambrisentan and theophylline']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo for comparison group', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59812', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana Center for Work Physiology and Exercise Metabolism', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Montana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Montana Center for Work Physiology and Exercise Metabolism', 'investigatorFullName': 'Brent Ruby', 'investigatorAffiliation': 'University of Montana'}}}}