Viewing Study NCT00252733

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Ignite Creation Date: 2025-12-25 @ 2:49 AM
Ignite Modification Date: 2025-12-26 @ 1:31 AM
Study NCT ID: NCT00252733
Status: COMPLETED
Last Update Posted: 2014-05-14
First Post: 2005-11-10
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Diabetic Retinopathy Candesartan Trials
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077793', 'term': 'candesartan cilexetil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+46 31 7766310', 'title': 'Niklas Berglind, GPS Atacand', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During treatment, up to 5 years.', 'description': 'The population used was the safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-randomization data were available.', 'eventGroups': [{'id': 'EG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily', 'otherNumAtRisk': 710, 'otherNumAffected': 85, 'seriousNumAtRisk': 710, 'seriousNumAffected': 102}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Comparator', 'otherNumAtRisk': 710, 'otherNumAffected': 43, 'seriousNumAtRisk': 710, 'seriousNumAffected': 112}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 43}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphoid Tissue Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Basedow's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coeliac Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mallory-Weiss Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancreatitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Generalised Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anogenital Warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pilonidal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cat Scratch Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hand Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Head Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Multiple Injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Femoral Neck Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Foreign Body In Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 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11.0'}, {'term': 'Cervix Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Retroperitoneal Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diabetic Autonomic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Guillain-Barre Syndrome', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ureteric Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasal Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sleep Apnoea Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 710, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 710, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '178', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '217', 'spread': '0.086', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.821', 'ciLowerLimit': '0.673', 'ciUpperLimit': '1.001', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.', 'description': 'Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Rate of Change in Urinary Albumin Excretion Rate (UAER).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'OG000'}, {'value': '710', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'classes': [{'categories': [{'measurements': [{'value': '0.510', 'groupId': 'OG000', 'lowerLimit': '0.487', 'upperLimit': '0.534'}, {'value': '0.543', 'groupId': 'OG001', 'lowerLimit': '0.520', 'upperLimit': '0.566'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.', 'unitOfMeasure': 'log (µg/min)/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '711'}, {'groupId': 'FG001', 'numSubjects': '710'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '605'}, {'groupId': 'FG001', 'numSubjects': '618'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '92'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Multiple Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. 4514 patients type 1 diabetes were enrolled of whom 1421 proceeded to randomization, 711 to the candesartan arm and 710 to the placebo arm.', 'preAssignmentDetails': 'The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '711', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '1421', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Comparator'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.60', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '29.90', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '29.75', 'spread': '8.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '298', 'groupId': 'BG000'}, {'value': '318', 'groupId': 'BG001'}, {'value': '616', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '805', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2005-11-10', 'resultsFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2005-11-14', 'lastUpdatePostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-19', 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a 2-step or Greater Increase in Early Treatment Diabetic Retinopathy Study (ETDRS) Severity Scale.', 'timeFrame': 'From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.', 'description': 'Two steps were defined as either a 1-step change in each eye or as a 2-step change in one eye only. ETDRS is a scale with 11 steps (1-11, where a score of 1 represents no retinopathy and a score of 11 represents proliferative retinopathy). A generalized log-rank test was used to test difference between treatments.'}], 'secondaryOutcomes': [{'measure': 'Rate of Change in Urinary Albumin Excretion Rate (UAER).', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'An estimate of the slope from fitting a linear regression of log(UAER) over time for each patient.'}]}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Insulin-Dependent'], 'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '38682786', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.'}, {'pmid': '21309844', 'type': 'DERIVED', 'citation': 'Sjolie AK, Klein R, Porta M, Orchard T, Fuller J, Parving HH, Bilous R, Aldington S, Chaturvedi N. Retinal microaneurysm count predicts progression and regression of diabetic retinopathy. Post-hoc results from the DIRECT Programme. Diabet Med. 2011 Mar;28(3):345-51. doi: 10.1111/j.1464-5491.2010.03210.x.'}, {'pmid': '21225239', 'type': 'DERIVED', 'citation': 'Porta M, Hainer JW, Jansson SO, Malm A, Bilous R, Chaturvedi N, Fuller JH, Klein R, Orchard T, Parving HH, Sjolie AK; DIRECT Study Group. Exposure to candesartan during the first trimester of pregnancy in type 1 diabetes: experience from the placebo-controlled DIabetic REtinopathy Candesartan Trials. Diabetologia. 2011 Jun;54(6):1298-303. doi: 10.1007/s00125-010-2040-1. Epub 2011 Jan 12.'}, {'pmid': '19451554', 'type': 'DERIVED', 'citation': 'Bilous R, Chaturvedi N, Sjolie AK, Fuller J, Klein R, Orchard T, Porta M, Parving HH. Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. Ann Intern Med. 2009 Jul 7;151(1):11-20, W3-4. doi: 10.7326/0003-4819-151-1-200907070-00120. Epub 2009 May 18.'}, {'pmid': '18823656', 'type': 'DERIVED', 'citation': 'Chaturvedi N, Porta M, Klein R, Orchard T, Fuller J, Parving HH, Bilous R, Sjolie AK; DIRECT Programme Study Group. Effect of candesartan on prevention (DIRECT-Prevent 1) and progression (DIRECT-Protect 1) of retinopathy in type 1 diabetes: randomised, placebo-controlled trials. Lancet. 2008 Oct 18;372(9647):1394-402. doi: 10.1016/S0140-6736(08)61412-9. Epub 2008 Sep 25.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=308&filename=CSR-D2453C00045.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=308&filename=CSR-D2453C00045.pdf', 'label': 'CSR-D2453C00045.pdf'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether candesartan, compared to placebo reduces the incidence of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients without retinopathy.\n\nThe secondary objective is to determine whether candesartan, compared to placebo, beneficially influences the rate of change in urinary albumin excretion rate (UAER).\n\nThis study is part of the DIRECT Programme also including secondary prevention studies of diabetic retinopathy in both type 1 and type 2 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included.\n* Duration of diabetes for \\> 1 year and \\< 15 years with stable diabetic therapy within last 6 months.\n* Patients with untreated resting mean sitting SBP \\< 130 mmHg, mean sitting DBP \\< 85 mmHg and with retinal photograph grading level 10/10 (on ETDRS severity scale).\n\nExclusion Criteria:\n\n* Patients with the following conditions are excluded from participation in the study:\n* Cataract or media opacity of a degree which precludes taking gradable retinal photographs\n* Angle closure glaucoma, which precludes pharmacological dilatation of the pupil\n* History of retinopathy\n* History or presence of clinical significant macular oedema (CSME)\n* History or evidence of photocoagulation of the retina Other retinal conditions which may mask assessment, eg, retinal vein occlusion\n* Positive micral dipstick test\n* Presence of secondary diabetes\n* Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception\n* Need of treatment with ACE-inhibitor\n* Haemodynamically significant aortic or mitral valve stenosis\n* Known renal artery stenosis or kidney transplantation\n* Hypersensitivity to study drug\n* Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00252733', 'acronym': 'DIRECT', 'briefTitle': 'Diabetic Retinopathy Candesartan Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients Without Retinopathy.', 'orgStudyIdInfo': {'id': 'D2453C00045'}, 'secondaryIdInfos': [{'id': 'DIRECT'}, {'id': 'SH-AHM-0045'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1', 'description': 'Placebo'}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'candesartan cilexetil', 'interventionNames': ['Drug: candesartan cilexetil']}], 'interventions': [{'name': 'candesartan cilexetil', 'type': 'DRUG', 'otherNames': ['ATACAND'], 'description': '32 mg once daily oral tablet given over 60 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herston', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'city': 'Perth', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'Research Site', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'AstraZeneca Atacand Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}