Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000838213
Ethics application status
Approved
Date submitted
18/09/2009
Date registered
6/01/2006
Date last updated
25/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Olmesartan Clinical Trial in Okinawan Patients Under Okinawa Dialysis Study
Scientific title
Multicenter, Randomized, Parallel Study of Angiotensin Receptor Blockade (Olmesartan) on mortality and morbidity in Chronic Hemodialysis Patients Among Okinawa Dialysis Study Group
Secondary ID [1] 989 0
CRG010600030
Universal Trial Number (UTN)
Trial acronym
OCTOPUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic hemodialysis patients (3/week) 243650 0
Hypertension 243878 0
Condition category
Condition code
Renal and Urogenital 252051 252051 0 0
Kidney disease
Cardiovascular 252093 252093 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 241311 0
Treatment: Drugs
Comparator / control treatment
Control of hypertension either by Olmesartan (ARB) plus conventional vs. conventional (without ARB). Conventional antihypertensie drugs by oral tablet or capsule are calcium channel blockers, beta-blockers, alfra- blockers, and sympathomimetics. Any kinds of antihypertensive drugs other than ARB can be used in the conventional treatment group from small dose such as 1 tablet or capsule. Treatment goal is the same as ARB group which is 140/90 mmHg or less at pre-HD setting.
Duration of treatment and follow up will be 2 years after the last patient’s registration which is June 2011.
Control group
Active

Outcomes
Primary outcome [1] 240728 0
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.
Timepoint [1] 240728 0
At three years after the last randomisation
Primary outcome [2] 252953 0
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.
Timepoint [2] 252953 0
At three years after the last randomisation
Primary outcome [3] 252954 0
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.
Timepoint [3] 252954 0
At three years after the last randomization
Secondary outcome [1] 257384 0
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.
Timepoint [1] 257384 0
At three years after the last randomisation
Secondary outcome [2] 257686 0
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.
Timepoint [2] 257686 0
every 4 weeks until three years after the last randomisation

Eligibility
Key inclusion criteria
1. Chronic hemodialysis patients (3/week),

2. High predialysis systolic blood pressure >140mmHg or

High predialysis diastolic blood pressure >90mmHg, or Both
Minimum age
20 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by fax wil be done by the coordinating center which is independet to the primary investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We adopted “Simple randomisation by using a randomisation table created by a computer software (i.e., computerised seq uence generation).” For this, we used sex and primary renal disease either diabetes mellitus (DM) or not-DM.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
462
Accrual to date
Final
Recruitment outside Australia
Country [1] 2000 0
Japan
State/province [1] 2000 0
Okinawa

Funding & Sponsors
Funding source category [1] 243762 0
Self funded/Unfunded
Name [1] 243762 0
Country [1] 243762 0
Primary sponsor type
Individual
Name
Kinitoshi Iseki
Address
Dialysis Unit, University Hospital of The Ryukyus, 207 Uehara, Nishihara, Okinawa 903-0215
Country
Japan
Secondary sponsor category [1] 237119 0
None
Name [1] 237119 0
Address [1] 237119 0
Country [1] 237119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243892 0
Ethic Committee of the University of the Ryukyus
Ethics committee address [1] 243892 0
207 Uehara, Nishihara, Okinawa 903-0215, Japan
Ethics committee country [1] 243892 0
Japan
Date submitted for ethics approval [1] 243892 0
31/10/2005
Approval date [1] 243892 0
17/11/2005
Ethics approval number [1] 243892 0

Summary
Brief 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.
Trial website
NA
Trial related presentations / publications
Clin Exp nephrol 13; 145-151, 2009
Public notes

Contacts
Principal investigator
Name 30138 0
Address 30138 0
Country 30138 0
Phone 30138 0
Fax 30138 0
Email 30138 0
Contact person for public queries
Name 13385 0
A/Prof, Kunitoshi, Iseki
Address 13385 0
Associate Professor of Medicine, Dialysis Unit, University Hospital of The Ryukyus, 207 Uehara, Nishihara, Okinawa 903-0215, Japan
Country 13385 0
Japan
Phone 13385 0
81-98-895-1341
Fax 13385 0
81-98-895-1473
Email 13385 0
chihokun@med.u-ryukyu.ac.jp
Contact person for scientific queries
Name 4313 0
Prof, Shinichiro, Ueda
Address 4313 0
Professor of medicine, Clinical pharmacology, Faculty of medicine, University of The Ryukyus, 207 Uehara, Nishihara, Okinawa 903-0215, Japan
Country 4313 0
Japan
Phone 4313 0
81-98-895-1195
Fax 4313 0
81-98-895-1447
Email 4313 0
suedano9@dream.com

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