UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016123 |
|---|---|
| Receipt number | R000018727 |
| Scientific Title | Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2016/07/05 18:05:17 |
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Basic information
Public title
Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Acronym
Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Scientific Title
Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Scientific Title:Acronym
Effect of an N/L-type Ca channel blocker on prorenin and soluble (pro)renin receptor levels in hypertensive patients: A randomized controlled trial
Region
| Japan |
Condition
Condition
Essential hypertension
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of Ca channel blockers on the prorenin-soluble (pro)renin system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma levels of prorenin and soluble (pro)renin receptor
Key secondary outcomes
1, blood pressure, pulse rate
2, renal function: urinary protein/creatinine ratio, urinary albumin/creatinine ratio, eGFR, cystatin C, pentosidine
3, renin-angiotenin system: plasma renin activity, plasma renin concentration, plasma aldosterone concentration
4, sympathetic nervous system: catecholamine
5, oxidative stress marker:
urine 8-OHdG
6, vascular endothelial function: flow-mediated dilation(FMD)
7, atherosclerosis: cardio-ankle vascular index(CAVI), augmentation index(AI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are treated with amlodipine.
Interventions/Control_2
Patients are treated with cilnidipine.
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
Essential hypertensive patients who were treated in the department of
medicine II, Tokyo Women's medical university, and fulfilled following conditions were enrolled:
1, systolic blood pressure <180mmHg
and diastolic blood pressure <110mmHg.
2, untreated or treated only with anti-hypertensive drugs except calcium channel blockers.
Key exclusion criteria
1,Patients with chronic kidney disease (CKD) stage 4 or greater
2,Patients with past histories of myocardial or cerebral infarction within the previous six months
3,Expectant mothers and lactating women
4,Patiens who have allergy to amlodipine or cilnidipine
Target sample size
100
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 hypertension and endocrinology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL
03-3353-8111
dwatanabe@endm.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Watanabe |
Organization
Tokyo Women's Medical University
Division name
Department of hypertension and endocrinology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ward, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
dwatanabe@endm.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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 | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018727
