Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-03-31 @ 7:21 PM
Study NCT ID:
NCT00185159
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olmesartan Medoxomil in Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], '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': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068557', 'term': 'Olmesartan Medoxomil'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-19', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the first occurrence of microalbuminuria defined as excretion of greater than 35 mg albumin/g urine creatinine for women and greater than 25 mg albumin/g urine creatinine for men in morning spot urine', 'timeFrame': 'Time to the first occurrence'}], 'secondaryOutcomes': [{'measure': 'Incidence of cardiovascular mortality and morbidity', 'timeFrame': 'Time to occurence'}, {'measure': 'Incidence of renal disease, such as worsening of renal function as well as end-stage (dialysis)', 'timeFrame': 'Time to occurrence'}, {'measure': 'Occurrence and progression of retinopathy', 'timeFrame': 'Time to occurence'}, {'measure': 'Treatment effects on a combined endpoint of cardiovascular mortality and morbidity and renal disease', 'timeFrame': 'Time to occurrence'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Throughout entire study'}]}, 'conditionsModule': {'keywords': ['Microalbuminuria'], 'conditions': ['Diabetes Mellitus, Type 2', 'Cardiovascular Disease', 'Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '36975019', 'type': 'DERIVED', 'citation': 'Do DV, Han G, Abariga SA, Sleilati G, Vedula SS, Hawkins BS. Blood pressure control for diabetic retinopathy. Cochrane Database Syst Rev. 2023 Mar 28;3(3):CD006127. doi: 10.1002/14651858.CD006127.pub3.'}, {'pmid': '29035939', 'type': 'DERIVED', 'citation': 'Chatzikyrkou C, Menne J, Izzo J, Viberti G, Rabelink T, Ruilope LM, Rump C, Mertens PR, Haller H. Predictors for the development of microalbuminuria and interaction with renal function. J Hypertens. 2017 Dec;35(12):2501-2509. doi: 10.1097/HJH.0000000000001491.'}, {'pmid': '24772521', 'type': 'DERIVED', 'citation': 'Menne J, Ritz E, Ruilope LM, Chatzikyrkou C, Viberti G, Haller H. The Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) observational follow-up study: benefits of RAS blockade with olmesartan treatment are sustained after study discontinuation. J Am Heart Assoc. 2014;3(2):e000810. doi: 10.1161/jaha.114.000810.'}, {'pmid': '22418908', 'type': 'DERIVED', 'citation': 'Menne J, Izzo JL Jr, Ito S, Januszewicz A, Katayama S, Chatzykirkou C, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G, Haller H; ROADMAP investigators. Prevention of microalbuminuria in patients with type 2 diabetes and hypertension. J Hypertens. 2012 Apr;30(4):811-8; discussion 818. doi: 10.1097/HJH.0b013e328351856d.'}, {'pmid': '21388309', 'type': 'DERIVED', 'citation': 'Haller H, Ito S, Izzo JL Jr, Januszewicz A, Katayama S, Menne J, Mimran A, Rabelink TJ, Ritz E, Ruilope LM, Rump LC, Viberti G; ROADMAP Trial Investigators. Olmesartan for the delay or prevention of microalbuminuria in type 2 diabetes. N Engl J Med. 2011 Mar 10;364(10):907-17. doi: 10.1056/NEJMoa1007994.'}, {'pmid': '21150933', 'type': 'DERIVED', 'citation': 'Januszewicz A, Ritz E, Viberti G, Mimran A, Rabelink AJ, Rump LC, Ruilope LM, Katayama S, Ito S, Izzo JL Jr, Haller H. Office and ambulatory pulse pressure--association with clinical characteristics and cardiovascular risk factors in normoalbuminuric patients with type 2 diabetes (ROADMAP study). J Hum Hypertens. 2011 Nov;25(11):679-85. doi: 10.1038/jhh.2010.111. Epub 2010 Dec 9.'}, {'pmid': '19876613', 'type': 'DERIVED', 'citation': 'Ritz E, Viberti GC, Ruilope LM, Rabelink AJ, Izzo JL Jr, Katayama S, Ito S, Mimran A, Menne J, Rump LC, Januszewicz A, Haller H. Determinants of urinary albumin excretion within the normal range in patients with type 2 diabetes: the Randomised Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) study. Diabetologia. 2010 Jan;53(1):49-57. doi: 10.1007/s00125-009-1577-3. Epub 2009 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'This is a study in diabetic patients with at least one additional cardiovascular risk factor and normoalbuminuria prior to randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus type 2, defined as fasting blood glucose of greater than or equal to 126 mg/dL;\n* Presence of at least one of the following cardiovascular risk factors:\n\n 1. total cholesterol greater than 200 mg/dL or statin treatment,\n 2. High density lipoprotein (HDL) less than 40 mg/dL,\n 3. triglycerides greater than 150 mg/dL and less than 400 mg/dL,\n 4. blood pressure greater than or equal to 130/80 mmHg,\n 5. Body mass index (BMI) greater than 28 kg/m2,\n 6. waist circumference greater than 102 cm for men and greater than 88 cm for women,\n 7. smoking of more than 5 cigarettes a day;\n* Normoalbuminuria at screening\n\nExclusion Criteria:\n\n* Severe uncontrolled hyperlipidemia;\n* Documented renal and/or renal-vascular disease;\n* Myocardial infarction, stroke or myocardial revascularization within the last 6 months;\n* History of alcohol and/or drug abuse;\n* Allergic reaction, lack of response or contraindication to angiotensin receptor blockers (ARBs);\n* Current treatment with an ARB or angiotensin converting enzyme (ACE) inhibitor'}, 'identificationModule': {'nctId': 'NCT00185159', 'briefTitle': 'Olmesartan Medoxomil in Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study (ROADMAP)', 'orgStudyIdInfo': {'id': 'SE-866/44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'olmesartan medoxomil', 'interventionNames': ['Drug: Olmesartan medoxomil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo', 'interventionNames': ['Drug: Placebo Tablets']}], 'interventions': [{'name': 'Olmesartan medoxomil', 'type': 'DRUG', 'description': 'tablets', 'armGroupLabels': ['1']}, {'name': 'Placebo Tablets', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Darmstadt', 'country': 'Germany', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}], 'overallOfficials': [{'name': 'Prof. Hermann Haller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Hochschule Hannover Klinik fur Nieren, Hannover Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sankyo Pharma Gmbh', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Heiko Rauer', 'oldOrganization': 'Daiichi Sankyo Europe, GmbH'}}}}