ActivePhase 4ACTRN12609000838213

Olmesartan Clinical Trial in Okinawan Patients Under Okinawa Dialysis Study

Multicenter, Randomized, Parallel Study of Angiotensin Receptor Blockade (Olmesartan) on mortality and morbidity in Chronic Hemodialysis Patients Among Okinawa Dialysis Study Group

Sponsor

Kinitoshi Iseki

Enrollment

462 participants

Start Date

Jun 1, 2006

Study Type

Interventional

Conditions

Hypertension chronic hemodialysis patients (3/week)

Summary

Guidelines for treatment of hypertension are not available for chronic hemodialysis (HD) population despite high mortality rate due to cardiovascular disease (CVD). Target levels of blood pressure and the class of antihypertensive drugs are not examined in prospective studies. We designed a prospective randomized controlled study among hypertensive HD patients in Okinawa (Okinawa Dialysis Study, OKIDS). The outcomes were compared between two treatment regimens such as 1) renin-angiotensin system (RAS) inhibitor Olmesartan and others, and 2) antihypertensive drugs without RAS inhibitors, in a parallel fashion. The title of the study is Olmesartan Clinical Trial in Okinawan Patients Under OKIDS (OCTOPUS). Outcomes are any cause of death and CVD in 3 years in a total of 462 patients. Subjects are age 20 to 79 years and ambulatory on thrice HD. Eligible patients are resistant hypertension: pre-HD session blood pressure 140/90 mmHg and over for more than 1 month regardless with the use of antihypertensive drugs. Patients treated with RAS drugs are eligible if they continue to be hypertensive for more than 1 month after switching to non-RAS antihypertensive drugs. This study provides evidence for the target levels of blood pressure at pre-HD session and the impact of RAS inhibitors. We also evaluated the usefulness of home blood pressure monitoring in HD patients.

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 79 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether the blood pressure medication olmesartan can help manage high blood pressure in dialysis patients aged 20 to 79 who undergo hemodialysis three times a week in Okinawa, Japan.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.