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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010170
Receipt No. R000010876
Scientific Title Studies on the antihypertensive effect and uric acid metabolism by the combination therapy of ARB and diuretics in the CKD patients with hypertension - Comparison between daily and alternate-daily medication of diuretics -
Date of disclosure of the study information 2013/03/05
Last modified on 2016/09/29

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Basic information
Public title Studies on the antihypertensive effect and uric acid metabolism by the combination therapy of ARB and diuretics in the CKD patients with hypertension
- Comparison between daily and alternate-daily medication of diuretics -
Acronym Intermittent removal of thiazide diuretics for treatment of hypertension in CKD patients study (INTERVAL study)
Scientific Title Studies on the antihypertensive effect and uric acid metabolism by the combination therapy of ARB and diuretics in the CKD patients with hypertension
- Comparison between daily and alternate-daily medication of diuretics -
Scientific Title:Acronym Intermittent removal of thiazide diuretics for treatment of hypertension in CKD patients study (INTERVAL study)
Region
Japan

Condition
Condition The CKD patients with hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the antihypertensive effects and the influences on some metabolic systems by the daily and alternate-daily combination medication of a thiazide diuretics, trichlormethiazide in the CKD patients with hypertension whose blood pressures have not yet achieved the target BP level by an ARB, irbesartan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1. Change of blood pressure (office blood pressure, home blood pressure)
2. Changes of serum uric acid level
Key secondary outcomes 1. Changes in renal function (serum creatinine, eGFR, serum cystatin C et al.)
2. Changes in urinary examinations (urine protein et al.)
3. Changes of metabolic biomarkers (lipids, glucose and electrolytes)
4. Changes of heart rate

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Daily administration of irbesartan 100mg with trichrolmethiazide 0.5-1mg
Interventions/Control_2 Administration of irbesartan 100mg daily with tricholmethiazide 1-2mg every other day
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Chronic kidney disease
2) Patients without acute changes in renal function and with stability in general condition
3) Hypertensive patients during treatment with antihypertensive drugs, or hypertensive patients whose blood pressures have not achieved to the targeted level recommended by "CKD guideline 2012"
4) Patients over the age of 20, unquestioned gender
5) The patients who we can obtain the informed consent signed by themselves.
Key exclusion criteria 1) The patient with contraindication of irbesartan medication
1. Patients with a history of hypersensitivity to any component of this drug
2. Patients during pregnancy and with pregnant possibility
2) The patient with contraindication of the trichrolmethiazide medication
1. Patients with anuria
2. Patients with acute renal failure
3. Patients with hyponatremia, and hypokalemia
4. Patients with a history of hypersensitivity to thiazides or analogues
3) Patients who are judged ineligible for any other reasons by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunya Uchida
Organization Teikyo University School of Medicine
Division name Department of Internal Medcine
Zip code
Address 11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL 03-3964-1211
Email uchidashunya@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shunya Uchida
Organization Teikyo University School of Medicine
Division name Department of Internal Medcine
Zip code
Address 11-1, Kaga 2-chome, Itabashi-ku, Teikyo, Japan
TEL 03-3964-1211
Homepage URL
Email uchidasyunya@gmail.com

Sponsor
Institute Department of Internal Medcine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Department of Internal Medcine, Teikyo University School of Medicine
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 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 05 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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 05 Day
Last modified on
2016 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010876

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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