Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT00252720
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2005-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
DIabetic Retinopathy Candesartan Trials.
Sponsor:
Organization:
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': 'C081643', 'term': 'candesartan'}, {'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. During Treatment refers to the period of actual treatment with randomized study drug, ie, is a subset of the patients included in During Study. During Treatment period only includes AEs reported while patients were on study treatment.', 'description': 'Population used was the safety population which includes all patients who received at least 1 dose of randomized study strug and for whom any post-dose data were available.', 'eventGroups': [{'id': 'EG000', 'title': 'Candesartan', 'description': 'Candesartan cilexetil 32 mg once daily', 'otherNumAtRisk': 951, 'otherNumAffected': 92, 'seriousNumAtRisk': 951, 'seriousNumAffected': 173}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Comparator', 'otherNumAtRisk': 951, 'otherNumAffected': 32, 'seriousNumAtRisk': 951, 'seriousNumAffected': 161}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 32}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Idiopathic Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenic Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cardiovascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Heart Disease Congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepato-Lenticular Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sudden Hearing Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vestibular Neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': "Addison's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diabetic Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal Fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Change Of Bowel Habit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Coeliac Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Duodenal Ulcer Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gingival Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hiatus Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rectal Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Foreign Body Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Macrosomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis Toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pilonidal Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal Wall Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Adnexitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Carbuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Corneal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Encephalitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Femoral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 951, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 951, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', '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': '127', 'spread': '0.034', 'groupId': 'OG000'}, {'value': '124', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8487', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.024', 'ciLowerLimit': '0.800', 'ciUpperLimit': '1.312', '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': 'Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized 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': 'Number of Participants With a Regression of Diabetic Retinopathy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', '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': '140', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '139', 'spread': '0.039', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to the end of the study, i.e., 5 years', 'description': 'Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).', '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': 'Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '951', 'groupId': 'OG000'}, {'value': '954', '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': '110', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '107', 'spread': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population was the Intention To Treat population whick 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': '951', 'groupId': 'OG000'}, {'value': '954', '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': '0.569', 'groupId': 'OG000', 'lowerLimit': '0.489', 'upperLimit': '0.648'}, {'value': '0.642', 'groupId': 'OG001', 'lowerLimit': '0.563', 'upperLimit': '0.722'}]}]}], '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 (post-randimisation, yearly assessments) 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 randimized 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': '951'}, {'groupId': 'FG001', 'numSubjects': '954'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '819'}, {'groupId': 'FG001', 'numSubjects': '789'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '165'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Moving', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Mainly patients lost to follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], '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. The study investigators enrolled 4514 patients with type 1 diabetes to either Study 45 or 46, of whom 1905 proceeded to randomization into Study 46 (1421 into Study 45).', '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': '951', 'groupId': 'BG000'}, {'value': '954', 'groupId': 'BG001'}, {'value': '1905', '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, 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': '951', 'groupId': 'BG000'}, {'value': '954', 'groupId': 'BG001'}, {'value': '1905', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '31.9', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '31.7', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '401', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '538', 'groupId': 'BG000'}, {'value': '553', 'groupId': 'BG001'}, {'value': '1091', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '595', 'groupId': 'BG000'}, {'value': '619', 'groupId': 'BG001'}, {'value': '1214', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 1850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-09', 'studyFirstSubmitDate': '2005-11-10', 'resultsFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2005-11-14', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-09', 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) 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': 'Retinopathy progression was defined as the first occurrence of at least a 3-step increase in the ETDRS severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Regression of Diabetic Retinopathy.', 'timeFrame': 'From baseline to the end of the study, i.e., 5 years', 'description': 'Regression of diabetic retinopathy was defined as at least a 3 step improvement or a persistent 2-step improvement (confirmed in 2 consecutive photography sets) in the Early Treatment of Diabetic Retinopathy Study (ETDRS) severity scale. 3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).'}, {'measure': 'Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).', 'timeFrame': 'From baseline to end of study, i.e. 5 years.', 'description': 'Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.'}, {'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 (post-randimisation, yearly assessments) for each patient'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus type 1'], '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=1268&filename=CSR-D2453C00046.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1268&filename=CSR-D2453C00046.pdf', 'label': 'CSR-D2453C00046.pdf'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy.\n\nThe secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate of change in urinary albumin excretion rate (UAER).\n\nThis study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in 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': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 - 55 years with 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 \\< 20 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 \\> 20/10 up to \\< 47/47 (on ETDRS severity scale).\n\nExclusion Criteria:\n\n* Patients with the following conditions are excluded from participation on 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 or presence of proliferative retinopathy\n* History or presence of clinical significant macular oedema (CSME)\n* History or evidence of photocoagulation of the retina\n* 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': 'NCT00252720', 'acronym': 'DIRECT', 'briefTitle': 'DIabetic Retinopathy Candesartan Trials.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'DIRECT: DIabetic Retinopathy Candesartan Trials. Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 1 Diabetic Patients With Retinopathy.', 'orgStudyIdInfo': {'id': 'D2453C00046'}, 'secondaryIdInfos': [{'id': 'DIRECT'}, {'id': 'SH-AHM-0046'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'candesartan', 'description': 'candesartan cilexetil 32 mg once daily', 'interventionNames': ['Drug: candesartan']}, {'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': 'control'}], 'interventions': [{'name': 'candesartan', 'type': 'DRUG', 'otherNames': ['ATACAND'], 'description': '32 mg oral tablet', 'armGroupLabels': ['candesartan']}]}, 'contactsLocationsModule': {'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'}}}}