UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of twenty-four-hour blood pressure control between candesartan and other ARBs estimated by the ambulatory blood pressure monitoring
Acronym	Effect of candesartan on 24-hours blood pressure control
Scientific Title	A comparison of twenty-four-hour blood pressure control between candesartan and other ARBs estimated by the ambulatory blood pressure monitoring
Scientific Title:Acronym	Effect of candesartan on 24-hours blood pressure control
Region	Japan

Condition
Condition	essential hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of 24-hour blood pressure control between candesartan and other angiotensin 2 receptor blockers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The difference of mean nocturnal blood pressure between candesartan and other angiotensin 2 receptor blockers.
Key secondary outcomes	The difference of mean 24-hour blood pressure between candesartan and other angiotensin 2 receptor blockers. The difference of mean morning blood pressure between candesartan and other angiotensin 2 receptor blockers. Percentage of the patient who achieved the target of 24-hour blood pressure in Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2009).

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Change ARB(except for candesartan) to candesartan.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with hypertension who are treated with ARB other than candesartan. Their blood pressure levels evaluated by ABPM do not achieve the goal of Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH 2009).
Key exclusion criteria	1. secondary hypertension 2. systolic blood pressure >160 mmHg and or diastolic blood pressure > 100 mmHg 3. malignant hypertension 4. history of stroke, myocardial infarction and other cardiovascular disease that needed hospitalization within recent 6 months. 5. atrial fibrillation 6. patients with fundal hemorrhage, exudation or papilledema due to hypertensive retinopathy 7. liver dysfunction(the levels of AST or ALT reached 250% of their upper normal limit.) 8. Renal dysfunction (serum creatinine > 2.0 mg/dl) 9. hyperkalemia (serum K > 5.5 mEq/l) 10. pregnant or nursing women 11. patients who are not recommended for participation in this study by physician in charge with medical reasons.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Higaki Jitsuo
Organization	Ehime University Graduate School of Medicine
Division name	Department of Integrated Medicine and Informatics
Zip code
Address	Shitsukawa Toon Ehime 791-0295 Japan
TEL	089-960-5302
Email

Public contact
Name of contact person	1st name Middle name Last name Okura Takafumi
Organization	Ehime University Graduate School of Medicine
Division name	Department of Integrated Medicine and Informatics
Zip code
Address	Shitsukawa, Toon, Ehime 791-0295 Japan
TEL	089-960-5302
Homepage URL
Email	okura@m.ehime-u.ac.jp

Sponsor
Institute	Department of Integrated Medicine, Ehime University Graduate Schoolof Medicine
Institute
Department

Funding Source
Organization	Ehime University
Organization
Division
Category of Funding Organization
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	愛媛大学医学部附属病院(愛媛県），済生会松山病院(愛媛県），松山赤十字病院(愛媛県），医療法人滴水会吉野病院(愛媛県），かとうクリニック(愛媛県），菅病院(愛媛県），鬼北町立北宇和病院(愛媛県） 　　 　　　 愛媛県東温市志津川

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 19 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	Terminated
Date of protocol fixation	2010 Year 02 Month 22 Day
Date of IRB	2010 Year 02 Month 22 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date	2012 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 09 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 31 Day
Last modified on	2019 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004369

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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