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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006342
Receipt No. R000007522
Scientific Title Effects of antihypertensive drugs on soluble (pro)renin receptor in hypertensive patients: open-label parallel-group controlled study
Date of disclosure of the study information 2011/11/01
Last modified on 2015/03/15

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Basic information
Public title Effects of antihypertensive drugs on soluble (pro)renin receptor in hypertensive patients: open-label parallel-group controlled study
Acronym Effects of antihypertensive drugs on soluble (pro)renin receptor
Scientific Title Effects of antihypertensive drugs on soluble (pro)renin receptor in hypertensive patients: open-label parallel-group controlled study
Scientific Title:Acronym Effects of antihypertensive drugs on soluble (pro)renin receptor
Region
Japan

Condition
Condition hypertension
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of each antihypertensive drugs on development and progression of organ damages and to clarify pathophysiological roles of these measurements by administering antihypertensive drugs in different categories to hypertensive patients, and measuring blood and urine levels of prorenin and soluble (pro)renin receptor.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood and urine prorenin and soluble (pro)renin receptor
Key secondary outcomes 1. Blood tests: biochemical measurements, hormones, oxidative stress markers, inflammatory markers, renin
2. Urine tests: pH, albumin/creatinine, hormones, oxidative stress markers, renin
3. Imaging tests: X-rays, CT, MRI, echography
4. Physiological tests: ECG, flow-mediated dilataion(FMD), cardio-anke vascular index(CAVI), augmentaion index(AI), ankle-brachial index(ABI), 24 hours ambulatory blood pressure monitoring(ABPM), visceral/subcutaneous fat ratio measurement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Renin-angiotensin system (RAS) blocker group: During 1-2 months of wash-out period, discontinue previously prescribed RAS blockers [angiotensin II receptor blocker (ARB), angiotensin converting enzyme (ACE) inhibitor, direct renin inhibitor (DRI)] which directly affect RAS, and prescribe antihypertensive drugs which belong to different categories. Then randomly assign patients to RAS blocker group or calcium channel blocker group. Set target blood pressure to <120/85 mmHg, <140/90 mmHg in elderlies, age above 65 year-old, <130/80 mmHg in patients with diabetes mellitus, chronic kidney disease or old myocardial infarction, <140/90 mmHg patients with cerebrovascular disease, according to hypertension treatment guideline 2009, established by the Japanese Society of Hypertension. To achieve the target blood pressure, gradually increase the dosage of the RAS blocker, and if the target blood pressure is not achieved by single agent, add-on drugs from different categories (diuretics, alpha-blockers, beta-blockers, alpha-methyldopa). Intervention period will be 3 years.
Interventions/Control_2 Calcium channel blocker (CCB) group: During 1-2 months of wash-out period, discontinue previously prescribed renin-agiotensin system (RAS) blockers [angiotensin II receptor blocker (ARB), angiotensin converting enzyme (ACE) inhibitor, direct renin inhibitor (DRI)] which directly affect RAS, and prescribe antihypertensive drugs which belong to different categories. Then randomly assign patients to RAS blocker group or CCB group. Set target blood pressure to <120/85 mmHg, <140/90 mmHg in elderlies, age above 65 year-old, <130/80 mmHg in patients with diabetes mellitus, chronic kidney disease or old myocardial infarction, <140/90 mmHg patients with cerebrovascular disease, according to hypertension treatment guideline 2009, established by the Japanese Society of Hypertension. To achieve the target blood pressure, gradually increase the dosage of the CCB, and if the target blood pressure is not achieved by single agent, add-on drugs from different categories (diuretics, alpha-blockers, beta-blockers, alpha-methyldopa). Intervention period will be 3 years.
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. Patient who fulfills the diagnostic criteria of hypertension
2. Patient who has been signed the consent form after sufficiently informed and fully understood the study
Key exclusion criteria 1. Patient with chronic kidney disease (CKD) stage 4 or 5
2. Patient whom director of the study disqualified
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Ichihara
Organization Tokyo Women's Medical University
Division name Department of medicine II
Zip code
Address 8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL 03-3353-8111
Email atzichi@endm.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanako Bokuda
Organization Tokyo Women's Medical University
Division name Department of medicine II
Zip code
Address 8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email kanakobkd@endm.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Other
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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2011 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 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
2011 Year 09 Month 14 Day
Last modified on
2015 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007522

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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