UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006342 |
|---|---|
| Receipt number | 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 17:51:21 |
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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
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
kanakobkd@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007522
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