UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004489
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email naritai@med.niigata-u.ac.jp

Public contact
1st 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
Email e-kouno@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.