Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-25 @ 2:41 PM
Study NCT ID:
NCT04212650
Status:
TERMINATED
Last Update Posted:
2023-10-30
First Post:
2019-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Losartan to Improve Hip Microfracture
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D003966', 'term': 'Camurati-Engelmann Syndrome'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spage@sprivail.org', 'phone': '970-401-8770', 'title': 'Suzanne Liv Page, JD', 'organization': 'Steadman Philippon Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Per opinion of the Principal Investigator, Losartan is now clinically indicated as a standard of care post-operative therapy for patients undergoing hip microfracture surgeries. The study was terminated early, resulting in a singular subject enrolled for data analysis. The subject elected to withdraw from the study prior to the first follow-up data collection timepoint.'}}, 'adverseEventsModule': {'timeFrame': '1 week', 'description': 'Participant was randomized to Losartan arm but withdrew before any follow up data was collected. Study closed.', 'eventGroups': [{'id': 'EG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Pain', 'notes': 'Patient presented with increased from baseline contralateral hip pain secondary to established labral tear during a standard of care post-operative visit for the study hip, which resulted in subsequent contralateral hip surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Drug related adverse events will be monitored during the medication phase (post-op days 2-31) and orthopaedic-related health and function will be monitored for the entire study duration (18 months).', 'description': 'Occurrence of treatment-emergent adverse events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'There was 1 subject enrolled into the Losartan arm, but withdrew before any follow-up data was collected. One serious adverse event was reported 3 days post-enrollment. This AE was determined to be unrelated to the research or study drug and is reported in the AE section.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': '12-question Short-Form General Health Survey (SF-12) - Including Physical Component Summary (PCS) and Mental Component Summary (MCS).\n\n* Higher score represents greater health.\n* Scale standardized to a US Population mean of 50 and standard deviation of 10 points.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline SF-12 PCS Score was 48.8 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Patient Satisfaction\n\n* Scale from 1-10.\n* Higher score represents greater patient satisfaction.', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient satisfaction is not collected at baseline. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Harris Hip Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Harris Hip Score (HHS).\n\n* Scale from 0-100.\n* Higher score represents greater hip health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline HHS Score was 57 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Hip Outcome Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Hip Outcome Score (HOS) - Including Sport and Activities of Daily Living (ADL) subscales.\n\n* Scale from 0-100.\n* Higher score represents greater hip health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline HOS-ADL Score was 68 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Including Pain, Stiffness and Physical Function subscales.\n\n* Scale from 0-96.\n* Higher score represents worse hip health.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline WOMAC Total Score was 31 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Tegner Activity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Tegner Activity Scale\n\n* Scale from 0-10.\n* Higher score represents greater activity level.', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline Tegner Activity Scale was unavailable for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Questionnaire - Numeric Rating Scale for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Numeric Rating Scale (NRS) for Pain\n\n* Scale from 1-10.\n* Higher score represents greater pain.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline NRS Pain Score was 6 for the 1 enrolled participant. Participant was randomized to Losartan arm but withdrew before any follow up data was collected.'}, {'type': 'SECONDARY', 'title': 'Morphological and Quantitative Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'timeFrame': 'Baseline and 12 months', 'description': 'Cartilage quality assessed by blinded radiologist using morphological MRI. Quantitative MRI using T2 mapping images with texture analysis used to assess water content and collagen organization within the cartilage and surrounding tissue.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant was randomized to Losartan arm but withdrew before any follow up data was collected.\n\nBaseline quantitative MRI was not processed due to participant withdrawal and study closure.'}, {'type': 'SECONDARY', 'title': 'Physical Examination of the Hip - Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'timeFrame': 'Baseline, 3 months, and 12 months', 'description': 'Standard physical exam assessment of hip strength, measured in Newtons.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant was randomized to Losartan arm but withdrew before any follow up data was collected.\n\nBaseline hip strength assessment data was not compiled due to participant withdrawal and study closure.'}, {'type': 'SECONDARY', 'title': 'Physical Examination of the Hip - Range of Motion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'timeFrame': 'Baseline, 3 months, and 12 months', 'description': 'Standard physical exam assessments of hip range of motion (ROM), measured in degrees.', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant was randomized to Losartan arm but withdrew before any follow up data was collected.\n\nBaseline hip range of motion assessment data was not compiled due to participant withdrawal and study closure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from The Steadman Clinic between March 2, 2020 and August 7, 2020. The first and last participant were enrolled on August 7, 2020.', 'preAssignmentDetails': 'Of 1 enrolled participant, 1 met inclusion criteria and was randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nLosartan: Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.\n\nPlacebo: Appearance-matched microcrystalline cellulose placebo'}, {'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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One (1) participant was enrolled in the study and subsequently randomized to the Losartan arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-27', 'size': 618881, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-23T11:57', 'hasProtocol': True}, {'date': '2020-05-15', 'size': 364413, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-21T17:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Block Randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'redesigned trial using another placebo controlled drug', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2019-12-19', 'resultsFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2019-12-24', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-25', 'studyFirstPostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Drug related adverse events will be monitored during the medication phase (post-op days 2-31) and orthopaedic-related health and function will be monitored for the entire study duration (18 months).', 'description': 'Occurrence of treatment-emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes Questionnaire', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': '12-question Short-Form General Health Survey (SF-12) - Including Physical Component Summary (PCS) and Mental Component Summary (MCS).\n\n* Higher score represents greater health.\n* Scale standardized to a US Population mean of 50 and standard deviation of 10 points.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Patient Satisfaction', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Patient Satisfaction\n\n* Scale from 1-10.\n* Higher score represents greater patient satisfaction.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Harris Hip Score', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Harris Hip Score (HHS).\n\n* Scale from 0-100.\n* Higher score represents greater hip health.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Hip Outcome Score', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Hip Outcome Score (HOS) - Including Sport and Activities of Daily Living (ADL) subscales.\n\n* Scale from 0-100.\n* Higher score represents greater hip health.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Including Pain, Stiffness and Physical Function subscales.\n\n* Scale from 0-96.\n* Higher score represents worse hip health.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Tegner Activity Scale', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Tegner Activity Scale\n\n* Scale from 0-10.\n* Higher score represents greater activity level.'}, {'measure': 'Patient Reported Outcomes Questionnaire - Numeric Rating Scale for Pain', 'timeFrame': 'Baseline, 3 months, 6 months, 12 months and 18 months', 'description': 'Numeric Rating Scale (NRS) for Pain\n\n* Scale from 1-10.\n* Higher score represents greater pain.'}, {'measure': 'Morphological and Quantitative Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Baseline and 12 months', 'description': 'Cartilage quality assessed by blinded radiologist using morphological MRI. Quantitative MRI using T2 mapping images with texture analysis used to assess water content and collagen organization within the cartilage and surrounding tissue.'}, {'measure': 'Physical Examination of the Hip - Strength', 'timeFrame': 'Baseline, 3 months, and 12 months', 'description': 'Standard physical exam assessment of hip strength, measured in Newtons.'}, {'measure': 'Physical Examination of the Hip - Range of Motion', 'timeFrame': 'Baseline, 3 months, and 12 months', 'description': 'Standard physical exam assessments of hip range of motion (ROM), measured in degrees.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cartilage Microfracture', 'Losartan', 'Transforming growth factor beta 1', 'Hip Arthroscopy'], 'conditions': ['Hip Osteoarthritis', 'Hip Impingement Syndrome', 'Cartilage Damage', 'Fibrosis']}, 'descriptionModule': {'briefSummary': 'Phase I/IIA randomized, double-blind, placebo-controlled clinical trial to assess safety and efficacy of oral losartan for improving cartilage repair following microfracture to treat focal cartilage defects during hip arthroscopy.', 'detailedDescription': "This is a prospective, double-blind, placebo-controlled, randomized clinical trial that will be conducted at The Steadman Clinic and Steadman Philippon Research Institute.\n\nArticular cartilage defects that extend full thickness to subchondral bone rarely heal without intervention. Some patients may not develop clinically significant problems from acute full-thickness chondral defects, but many eventually suffer from debilitating degenerative changes. Microfracture is the most commonly used first-line treatment technique for chondral lesions in the hip, however, this procedure's effectiveness is limited by the repair tissue being a hybrid of hyaline and fibrocartilage. We hypothesize that administration of a transforming growth factor beta 1 (TGF-β1) blocker, losartan (an approved hypertension drug, angiotensin II receptor antagonist) with microfracture will enhance articular cartilage repair as assessed on quantitative magnetic resonance imaging. We will also measure patient benefit through the recording of patient reported outcomes in the 18 months following surgery. The Division of Pulmonary, Allergy and Rheumatology Products within the Center for Drug Evaluation and Research at the Food and Drug Administration has granted an investigational new drug (IND) exemption to pursue this trial in accordance with 21 CFR 312.2(b)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Underwent primary hip arthroscopy\n* Underwent baseline quantitative MRI at The Steadman Clinic (TSC)\n* Single, localized, grade 3 or 4 cartilage lesion of the acetabulum or femoral head treated with Bone Marrow Stimulation (BMS; i.e. microfracture)\n* Aged 18-60 at time of surgery\n* Tonnis grade 1 or less\n\nExclusion Criteria:\n\n* Two or more cartilage lesions of grade 3 or 4\n* Less than 2 mm of minimal hip joint space\n* Osteoarthritis or diffuse change of cartilage\n* Non-English speaking\n* Prior hip surgery on operative hip\n* Pre-existing bony deformity caused by previous fracture(s)\n* Synovial chondromatosis\n* Pigmented Villonodular Synovitis (PVNS)\n* Dysplasia (center edge angle \\<20 degrees)\n* History of Avascular Necrosis (AVN), Perthes disease, or slipped capital femoral epiphysis (SCFE)\n* Inflammatory arthritis or other arthritis caused by autoimmune disease\n* Patients allergic to any active or inactive ingredient of losartan\n* Patients taking medication with known losartan interaction, including phenobarbital, rifampin, and fluconazole.\n* Subjects that are currently taking losartan'}, 'identificationModule': {'nctId': 'NCT04212650', 'briefTitle': 'Losartan to Improve Hip Microfracture', 'organization': {'class': 'OTHER', 'fullName': 'Steadman Philippon Research Institute'}, 'officialTitle': 'Biologically Regulated Marrow Stimulation by Blocking Fibrosis to Improve Cartilage Repair: A Randomized Double-Blind, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': '2019-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan', 'description': '12.5mg Losartan capsules, oral administration, twice daily (25mg total per day), taken for 30 consecutive days starting on the evening of the second post-surgery day.', 'interventionNames': ['Drug: Losartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Appearance-matched placebo capsules, oral administration, twice daily, taken for 30 consecutive days starting on the evening of the second post-surgery day.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Losartan Potassium'], 'description': 'Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.', 'armGroupLabels': ['Losartan']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Appearance-matched microcrystalline cellulose placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81657', 'city': 'Vail', 'state': 'Colorado', 'country': 'United States', 'facility': 'Steadman Philippon Research Institute', 'geoPoint': {'lat': 39.64026, 'lon': -106.3742}}], 'overallOfficials': [{'name': 'Marc J Philippon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steadman Philippon Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steadman Philippon Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Office of Naval Research (ONR)', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}