Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01009918
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2009-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}, {'id': 'D018567', 'term': 'Breast Neoplasms, Male'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077261', 'term': 'Carvedilol'}, {'id': 'D017706', 'term': 'Lisinopril'}], 'ancestors': [{'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mguglin@health.usf.edu', 'phone': '813-259-0600', 'title': 'Maya Guglin, MD, PhD', 'organization': 'University of South Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected for the duration of the study and 12 month follow-up period.', 'description': 'Adverse Events were collected from patient at each study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally', 'otherNumAtRisk': 158, 'deathsNumAtRisk': 158, 'otherNumAffected': 104, 'seriousNumAtRisk': 158, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 89, 'seriousNumAtRisk': 156, 'deathsNumAffected': 2, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally', 'otherNumAtRisk': 154, 'deathsNumAtRisk': 154, 'otherNumAffected': 82, 'seriousNumAtRisk': 154, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 21, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 134, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 81, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 68, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 60, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 43, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 53, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 45, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 28, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 130, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 107, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 126, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 26, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 23, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hot Flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 39, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 36, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nervous System Disorders - Other Specify', 'notes': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Neutrophil Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Spleen Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'White Blood Cell Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 154, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'OG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'OG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who experienced cardiotoxicity'}, {'type': 'PRIMARY', 'title': 'Number of Participants With LVEF Decrease to <50%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'OG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'OG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \\<50%', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'LVEF drop to \\<50%'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Trastuzumab Course Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'OG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'OG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Measure indicates the number of patients who had an interruption of trastuzumab for any reason', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who had an interruption of trastuzumab for any reason'}, {'type': 'SECONDARY', 'title': 'Quality-of-life Changes Between Baseline and 52-weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'OG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'OG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '23', 'groupId': 'OG000'}, {'value': '2', 'spread': '17', 'groupId': 'OG001'}, {'value': '5', 'spread': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean change from baseline to 52-week endpoint'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'OG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'OG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years', 'description': 'Number of Participants with cardiotoxicity-free survival at 750 days from baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of Participants with cardiotoxicity-free survival at 750 days from baseline'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'FG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'FG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '156'}, {'groupId': 'FG002', 'numSubjects': '154'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '132'}, {'groupId': 'FG002', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '30'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I Lisinopril', 'description': 'Patients receive oral lisinopril once daily.\n\nlisinopril: Given orally'}, {'id': 'BG001', 'title': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.\n\nCoreg CR®: Given orally'}, {'id': 'BG002', 'title': 'Arm III Placebo', 'description': 'Patients receive oral placebo once daily.\n\nplacebo: Given orally'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '50.58', 'spread': '10.91', 'groupId': 'BG000'}, {'value': '51.58', 'spread': '10.93', 'groupId': 'BG001'}, {'value': '51.11', 'spread': '10.32', 'groupId': 'BG002'}, {'value': '51.09', 'spread': '10.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '468', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '404', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '464', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.01', 'spread': '6.86', 'groupId': 'BG000'}, {'value': '28.26', 'spread': '6.17', 'groupId': 'BG001'}, {'value': '29.03', 'spread': '5.92', 'groupId': 'BG002'}, {'value': '28.43', 'spread': '6.33', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Did not have information for 4 participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-08-31', 'size': 522810, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-11T14:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2009-11-06', 'resultsFirstSubmitDate': '2021-01-12', 'studyFirstSubmitQcDate': '2009-11-06', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-29', 'studyFirstPostDateStruct': {'date': '2009-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Trastuzumab-Induced Cardiotoxicity After 52 Weeks of Treatment', 'timeFrame': '2 years', 'description': 'Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.'}, {'measure': 'Number of Participants With LVEF Decrease to <50%', 'timeFrame': '2 years', 'description': 'Number of Participants with Left Ventricular Ejection Fraction (LVEF) drop to \\<50%'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Trastuzumab Course Interruption', 'timeFrame': '2 years', 'description': 'Measure indicates the number of patients who had an interruption of trastuzumab for any reason'}, {'measure': 'Quality-of-life Changes Between Baseline and 52-weeks', 'timeFrame': '52 weeks', 'description': 'Quality-of-life changes as assessed by North European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), which measures the quality of life of cancer patients. Higher score indicates higher quality of life. Score range is 0-100. The questionnaire was administered at baseline and at 52 weeks.'}, {'measure': 'Number of Participants With Cardiotoxicity-free Survival at 750 Days From Baseline', 'timeFrame': '2 years', 'description': 'Number of Participants with cardiotoxicity-free survival at 750 days from baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiac toxicity', 'HER2-positive breast cancer', 'recurrent breast cancer', 'stage IA breast cancer', 'stage IB breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'male breast cancer'], 'conditions': ['Breast Cancer', 'Cardiac Toxicity']}, 'referencesModule': {'references': [{'pmid': '31171092', 'type': 'DERIVED', 'citation': 'Guglin M, Krischer J, Tamura R, Fink A, Bello-Matricaria L, McCaskill-Stevens W, Munster PN. Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer. J Am Coll Cardiol. 2019 Jun 11;73(22):2859-2868. doi: 10.1016/j.jacc.2019.03.495.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.\n\nPURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* The primary objective of this study is to determine if administration of lisinopril or Coreg CR®, compared to placebo, will reduce the incidence of trastuzumab-induced cardiotoxicity, as measured by LVEF, in patients receiving adjuvant, or neoadjuvant,therapy for HER2 positive breast cancer.\n\nSecondary\n\n* To determine whether subjects randomized to active agent have fewer interruptions in trastuzumab therapy due to cardiomyopathy.\n* To determine whether the treatment effect is consistent in anthracycline and nonanthracycline patient cohorts\n* To compare changes in HRQL among the treatment groups during the study intervention\n* To evaluate the long term effects on the prevention of cardiomyopathy and impact on HRQL for either or both study agents\n* To compare the predictive value of troponin I and BNP in the identification of trastuzumab-induced cardiotoxicity\n\nOUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.\n\n* Arm I: Patients receive oral lisinopril once daily.\n* Arm II: Patients receive oral Coreg CR® once daily.\n* Arm III: Patients receive oral placebo once daily.\n\nIn all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.\n\nQuality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).\n\nAfter completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Males and Females ≥ 18 years old diagnosed with HER2 positive breast cancer\n* Scheduled to receive neoadjuvant or adjuvant trastuzumab (Herceptin®) therapy (anthracycline-containing regimens are permitted). Patients receiving Herceptin® with their chemotherapy are permitted for eligibility work-up. Taxanes are permitted. Trastuzumab (Herceptin®) therapy may be given with or after primary chemotherapy. Pertuzumab may be used in conjunction with trastuzumab.\n* Left Ventricular Ejection Fraction (LVEF) ≥ 50% by MUGA scan or echocardiogram\n* Adequate renal function for administration of trastuzumab-containing chemotherapy regimen.\n* Sitting systolic blood pressure of \\> 90 mm Hg\n* Pulse ≥ 60 beats/minute\n* Not pregnant or breastfeeding\n* Female patients of childbearing potential, who are sexually active, must have a negative pregnancy test before starting the study\n* Both men and women must be willing to use effective contraception during the study. Teratogenicity is documented for both active study agents\n* Able to swallow capsules\n\nEXCLUSION CRITERIA:\n\n* Patients with metastatic disease\n* Prior treatment with trastuzumab or anthracyclines prior to this chemotherapy regimen\n* Current treatment with angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), such as losartan, β-blockers or digoxin\n* Known cardiac history: heart failure, myocardial infarction, radiation-induced cardiac dysfunction\n* Known allergy to either ACE inhibitors or β-blockers\n* History of bronchial asthma or related bronchospastic conditions\n* Hereditary or idiopathic angioedema\n* History of severe hypersensitivity reactions to drugs or other causes, i.e. bee stings\n* This protocol does not exclude patients who are participating on other investigational studies. Refer to the local IRB guidelines.'}, 'identificationModule': {'nctId': 'NCT01009918', 'briefTitle': 'Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)', 'orgStudyIdInfo': {'id': 'SCUSF 0806'}, 'secondaryIdInfos': [{'id': 'SCUSF-0806', 'type': 'OTHER', 'domain': 'SunCoast CCOP Research Base'}, {'id': '5U10CA081920-11', 'link': 'https://reporter.nih.gov/quickSearch/5U10CA081920-11', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I lisinopril', 'description': 'Patients receive oral lisinopril once daily.', 'interventionNames': ['Drug: lisinopril']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II Coreg CR®', 'description': 'Patients receive oral Coreg CR® once daily.', 'interventionNames': ['Drug: Coreg CR®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm III placebo', 'description': 'Patients receive oral placebo once daily.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Coreg CR®', 'type': 'DRUG', 'otherNames': ['carvedilol phosphate extended-release'], 'description': 'Given orally', 'armGroupLabels': ['Arm II Coreg CR®']}, {'name': 'lisinopril', 'type': 'DRUG', 'otherNames': ['Registered Trade names: Prinivil, Tensopril, Zestril, Hipril'], 'description': 'Given orally', 'armGroupLabels': ['Arm I lisinopril']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given orally', 'armGroupLabels': ['Arm III placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Todd Cancer Institute at Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View - UCLA Medical Center Foundation', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Presbyterian Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301-9019', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Boulder Community Hospital', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80933', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Penrose Cancer Center at Penrose Hospital', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Anthony Central Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Porter Adventist Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Presbyterian - St. Luke's Medical Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80222', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'CCOP - Colorado Cancer Research Program', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80631', 'city': 'Greeley', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Colorado Medical Center', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '80122', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Littleton Adventist Hospital', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'Sky Ridge Medical Center', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '80501', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Hope Cancer Care Center at Longmont United Hospital', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '80539', 'city': 'Loveland', 'state': 'Colorado', 'country': 'United States', 'facility': 'McKee Medical Center', 'geoPoint': {'lat': 40.39776, 'lon': -105.07498}}, {'zip': '80138', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Parker Adventist Hospital', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '81004', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'St. Mary - Corwin Regional Medical Center', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '80033', 'city': 'Wheat Ridge', 'state': 'Colorado', 'country': 'United States', 'facility': 'Exempla Lutheran Medical Center', 'geoPoint': {'lat': 39.7661, 'lon': -105.07721}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Ella Milbank Foshay Cancer Center at Jupiter Medical Center', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakeland Regional Cancer Center at Lakeland Regional Medical Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'CCOP - Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP - Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': "Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler", 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare - Bloomington', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '61520', 'city': 'Canton', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare - Canton', 'geoPoint': {'lat': 40.55809, 'lon': -90.03512}}, {'zip': '62321', 'city': 'Carthage', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois CancerCare - Carthage', 'geoPoint': {'lat': 40.41643, 'lon': -91.13625}}, {'zip': '60631', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Resurrection Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Louis A. 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