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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003417
Receipt No. R000004139
Scientific Title Efficacy and safety of switching from angiotensin II receptor blocker-diuretic combinations therapy to combination tablets (candesartan cilexetil-hydrochlorothiazide) in hypertension.
Date of disclosure of the study information 2010/04/01
Last modified on 2014/03/31

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Basic information
Public title Efficacy and safety of switching from angiotensin II receptor blocker-diuretic combinations therapy to combination tablets (candesartan cilexetil-hydrochlorothiazide) in hypertension.
Acronym BLOARD study
Scientific Title Efficacy and safety of switching from angiotensin II receptor blocker-diuretic combinations therapy to combination tablets (candesartan cilexetil-hydrochlorothiazide) in hypertension.
Scientific Title:Acronym BLOARD study
Region
Japan

Condition
Condition Hypertensive patients receiving combined therapy with candesartan cilexetil and diuretic
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of ECARD HD (candesartan cilexetil-hydrochlorothiazide) switched from combined therapy with candesartan cilexetil and diuretic
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Change in blood pressure (absolute value)
2.Changes in uric acid (absolute value)
Key secondary outcomes 1.TC, TG, HDL-C
2.BNP
3.cystatin C
4.blood glucose level (HbA1c, fasting blood sugar)
5.urinary albumin, urinary sodium
6.safety : serum potassium

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination tablets (ARB/diuretics)
ARB/diuretics combinations
Interventions/Control_2
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patient who was diagnosed as hypertension
2.Patient who recieves continuous candesartan and diuretic treatment
3.ambulatory patient
4.Patient who understands the contents of the informed consent form.
5.Patient who agrees with contraception during the study period
Key exclusion criteria 1.Patient who is anuric and/or dialysis
2.Patient with ARF (acute renal failure)
3.Patient with sodium - and potassium - depletion / sodium - and potassium - depleted patients
4.Patient who is pregnant or possibly pregnant
5.Patients with a history of hypersensitivity to ingredients of Ecard HD (candesartan cilexetil-hydrochlorothiazide) or other thiazide or thiazide-like diuretics
6.Patient who is determined to be excluded from the study due to any reason by the study doctor
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouji Kajinami
Organization Kanazawa Medical University Hospital
Division name Department of Cardiology
Zip code
Address 1-1 Daigaku,Uchinada,Kahoku,Ishikawa
TEL 076-286-2211
Email kajinami@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouji Kajinami
Organization Kanazawa Medical University Hospital
Division name Department of Cardiology
Zip code
Address 1-1 Daigaku,Uchinada,Kahoku,Ishikawa
TEL 076-286-2211
Homepage URL
Email kajinami@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University Hospital
Institute
Department

Funding Source
Organization Kanazawa Medical University Hospital
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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2010 Year 04 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 01 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 31 Day
Last modified on
2014 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004139

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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