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| autoid | 94 |
| crg_id | CRG010600030 |
| titleoftrial | Multicenter, Randomized, Parallel Study of Angiotensin Receptor Blockade (Olmesartan) in Chronic Hemodialysis Patients Among OKIDS Group |
| acronymnoftrial | Olmesartan Clinical Trial in Okinawan Patients Under OKIDS |
| website | http:// |
| identificationno | |
| leadprefix | A/Prof |
| leadsurname | Iseki |
| leadgivennames | Kunitoshi |
| leadposition | Associate Professor of Medicine |
| leaddepartment | Dialysis Unit |
| leadorganisation | University Hospital of The Ryukyus |
| leadaddress | 207 Uehara, Nishihara, Okinawa 903-0215, Japan |
| leademail | chihokun@med.u-ryukyu.ac.jp |
| leadphone | +81-98-895-1341 |
| leadfax | +81-98-895-1416 |
| leadsuffix | |
| contactprefix | Prof |
| contactsurname | Ueda |
| contactgivennames | Shinichiro |
| contactposition | Professor of medicine |
| contactdepartment | Clinical pharmacology |
| contactorganisation | Faculty of medicine, University of The Ryukyus |
| contactaddress | 207 Uehara, Nishihara, Okinawa 903-0215, Japan |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | other |
| otherfunding | Own funds gather ed at the dialysis unit |
| fundingnameofsponsors | |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 2006/04/01 |
| actualstart | |
| proposedcompletiondate | 2009/03/31 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 21-25 |
| multi_national_study | no |
| countrycentres | Japan |
| researchquestion | 1. Is Olmesartan (angiotensin receptor blockade) useful to reduce mortality rate and cardiovascular morbidity? 2. Is predialysis blood pressure useful as a target of control of hypertension? |
| study_status_recruitment | not_yet_recruiting |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | chronic hemodialysis patients (3/week) |
| intervention1 | Chronic hemodialysis, hypertension |
| intervention2 | angiotensin receptor blockade |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 20-79 |
| totalrecruitment | 1200 |
| inclusion | 1. Chronic hemodialysis patients (3/week),
2. High predialysis systolic blood pressure >140mmHg or High predialysis diastolic blood pressure >90mmHg, or Both |
| exclusion | 1. Recent onset (within one month) of cardiovascular disease and congestive heart failure
2. Severe hypertension (high predialysis systolic blood pressure >200mmHg or high predialysis diastolic blood pressure >100mmHg 3. Patient on angiotensin converting enzyme inhibitors (ACEI) or other angiotensin receptor blockades (ARB), (washoout at least one month) |
| primaryoutcomes | 1. Any cause of death |
| secondaryoutcomes | 1. New onset of cardiovascular disease such as acute myocardial infarction, stroke, and congestive heart failure
2. Occlusion of blood access 3. Change in Home Blood Pressure |
| reference | Iseki K, Tokuyama K, Shiohira Y, Higa A, Hirano H, Toma S, et al. Olmesartan clinical trial in Okinawan patients under OKIDS (OCTOPUS) study: design and methods.Clinical & Experimental Nephrology 2009 Apr;13(2):145-51. |