UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004489 |
|---|---|
| Receipt number | R000005301 |
| Scientific Title | comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2013/11/06 11:21:02 |
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Basic information
Public title
comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease
Acronym
TOKI Study
Scientific Title
comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease
Scientific Title:Acronym
TOKI Study
Region
| Japan |
Condition
Condition
Hypertensive patients with CKD under the treatment of the angiotensin receptor blocker(ARB), olmesartan medoxomil 20mg/day
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the antialbuminuric effect between the increased dose of olmesartan medoxomil to 40mg/day and the additional administration of azelnidipine 8 to 16mg/day in CKD hypertensive patients taking olmesartan medoxomil of 20mg/day.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment
Key secondary outcomes
1. blood pressure(Office,Home)
2. Pulse rate(Home)
3. Change in the urinary Alb/Cr ratio
4. Change in eGFR
5. Relationship between BMI and BP/urinary Alb/Cr ratio
6. Change in HbA1c levels
7. Change in urinary excretion of sodium
8. Change in serum uric acid
9. Change in urinary megalin and urinary podocalyxin
10. Cerebro-cardio-vascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olmesartan medoxomil is increased to 40mg/day in patients with the treatment of olmesartan medoxomil(20mg/day).If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB and RAS inhibitor is added.
Interventions/Control_2
Azelnidipine(8 to 16mg/day) is added in patients with the treatment of olmesartan medoxomil(20mg/day).If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB and RAS inhibitor is added.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients to fulfill all the following condition can participate
1) Outpatient systolic BP is equal or more than 130 and less than 180 and/or outpatient diastolic BP is equal or more than 85 and less than 110 mmHg.
2) Outpatients with CKD
3) eGFR is more than 30 mL/min/1.73m2.
4) Age is equal or more than 20 and less than 85 year-old.
5) Olmesartan medoxomil (20mg/day) has been administered for more than 3 months, and the other inhibitor of the renin-angiotensin inhibitor, CCB and diureteic have not been given within 3 months.
6) Written informed consent is obtained based on written and oral explanation of physician in charge.
Key exclusion criteria
1) Secondary hypertension or malignant hypertension (within hypertension in level 3)
2) Severe heart failure (NYHA Class is equal or more than III)
3) Atrial fibrillation or flutter with severe arrhythmia
4) Severe renal failure or liver failure (patient on dialysis, AST or ALT is more than 5 times higher upper limits)
5) Not appropriate for change to the test drugs from current therapy for coronary disease (i.e. CCB, diuretics, etc.)
6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic
7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis.
8) Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis.
9) Patients already used other CCB or a diuretic.
10) Pregnant, possible to be pregnant, or willing to be pregnant
11) Patients who are inadequate by determination of physician in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiei Narita |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Clinical Nephrology and Rheumatology
Zip code
Address
1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
TEL
025-227-2200
naritai@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Emiko Kono |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Clinical Nephrology and Rheumatology
Zip code
Address
1-757 Asahimachi-dori, chuo-ku,Niigata 951-8510, Japan
TEL
025-227-2200
Homepage URL
e-kouno@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
えきまえクリニック 内科はやし医院(新潟県)、わかばやし内科クリニック(新潟県)、岡田内科医院(新潟県)、小林医院(新潟県)、やぎさわクリニック(新潟県)、押木内科神経内科医院(新潟県)、鈴木内科小児科医院(新潟県)、新潟臨港病院（新潟県）、信楽園病院（新潟県）、済生会新潟第二病院（新潟県）、鷲塚内科医院（新潟県）、青柳医院（新潟県）、岡田内科医院（新潟県）、五十嵐医院（新潟県）、新潟医療センター病院（新潟県）、獨協医科大学越谷病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 01 | Day |
Last modified on
| 2013 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005301
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