Olmesartan Clinical Trial in Okinawan Patients Under Okinawa Dialysis Study

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2006
INTERVENTION: Control of hypertension, 140/90mmHg at pre‐hemodialysis (HD) by adding angiotensin recptor blockade (ARB) or non‐ARB. Target blood pressure (BP) levels is to lower 140/90mmHg at pre‐HD. In the active treatment period, patients will be assigned randomly to commence treatment with either 10 mg olmesartan medoxomil, oral capsue (or other treatment without angiotensin receptor blockers (ARB) and angiotensin converting enzyme inhibitors (AECI).) in addition to their existing antihypertensive therapy. If the target blood pressure of less than 140/90 mmHg is not achieved after the first of therapy or at any time thereafter, the dose of olmesartan medoxomil (or other treatment without angiotensin receptor blockers and angiotensin converting enzyme inhibitors.) will be increased to 20 mg daily oral tablet (or other treatment without angiotensin receptor blockers and angiotensin converting enzyme inhibitors), with further titration to a dose of olmesartan medoxomil 40 mg daily (or other treatment without angiotensin receptor blockers and angiotensin converting enzyme inhibitors), if necessary. Duration of treatment both conventional and olmesartan and follow up will be 2 years after the last patient’s registration which is June 2011. CONDITION: chronic hemodialysis patients (3/week) Hypertension PRIMARY OUTCOME: 1. Any cause of death. This information will be obtained through the collaboration of physicians and/or clinical research nurses which are recording in the clinical record files (CRF). All these information are gathered regularly. ; CRF of events will be reviewed by two outside reviewers which familiar with cardiovascular disease. Members of the independent Event Evaluation are Dr. Tagawa S and Dr. Inoue T. Any cause of death plus new onset of cardiovascular disease, stroke and congestive heart failure requiring hospitalization. CRF of events will be reviewed by two outside reviewers which familiar with cardiovascular disease. Members of the independent Event Evaluation are Dr. Tagawa S and Dr. Inoue T. New onset of cardiovascular disease, stroke, and congestive heart failure requiring hospitalization. CRF of events will be reviewed by two outside reviewers which familiar with cardiovascular disease. Members of the independent Event Evaluation are Dr. Tagawa S and Dr. Inoue T. SECONDARY OUTCOME: Changes in home blood pressure. Patients are provided automated sphygmomanometer, HITACHI 9700, to measure blood pressure at home. Blood pressure and the compliance to the drug therapy are monitored every 4 weeks. Data for HD blood pressure were obtained at three points for HD days and four points of non‐HD days for home blood pressure. Occlusion of vascular access. CRF of events will be reviewed by two outside reviewers which familiar with cardiovascular disease. Members of the independent. Event Evaluation are Dr. Tagawa S and Dr. Inoue T. INCLUSION CRITERIA: 1. Chronic hemodialysis patients (3/week), 2. High predialysis systolic blood pressure >140mmHg or High predialysis diastolic blood pressure >90mmHg, or Both
Epistemonikos ID: 882ad9623b75f2c3eeaf72abe6dee45df4cd73c8
First added on: Aug 21, 2024