UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006154 |
|---|---|
| Receipt number | R000007130 |
| Scientific Title | Restoration of Aldosterone Breakthrough by Aliskiren |
| Date of disclosure of the study information | 2011/08/12 |
| Last modified on | 2011/08/12 08:55:27 |
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Basic information
Public title
Restoration of Aldosterone Breakthrough by Aliskiren
Acronym
Restoration of Aldosterone Breakthrough
by Aliskiren
Scientific Title
Restoration of Aldosterone Breakthrough by Aliskiren
Scientific Title:Acronym
Restoration of Aldosterone Breakthrough
by Aliskiren
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evalutate the effects of aliskiren therapy for restoration of aldosterone breakthrough phenomenon in hypertensive patients treaed with ACE-I or ARB.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma aldosterone concentration
Improvement of hypertensive target organ damage measured as urinary albumin excretion ratio
Key secondary outcomes
Changes in 24hr blood pressure
Changes in left ventricular hypertrophy(electrocardiogram and echocardiography)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention
Switching ACE-I or ARB to aliskiren
Interventions/Control_2
Intervention
Poor blood pressure control
Add aliskiren to conventional anti-hypertensive therapy with ACE-I or ARB
Interventions/Control_3
Control
Conventional anti-hypertensive therapy with ACE-I or ARB
Interventions/Control_4
Control
Poor blood pressure control
Add Ca channel antagonist or diuretics to conventional anti-hypertenive therapy with ACE-I or ARB
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) Anti-hypertensive treatment with ACE-I or ARB
2) Plasma aldosterone concetraion is greater than 100pg/ml
3) Without taking aldostetone blocker
4) 20 years and older
5) Only outpatient
6) Male and Female
Key exclusion criteria
1)Left ventricular systolic dysfunction (LVEF is under 40% on echocardiography)
2)History of Acute coronary syndrome or stroke within 6 months
3)Serum Cr is over 2.0mg/dl
4)Serum potassium is over 5.0mmol/L
5)Hypertensivity or contraindication to aliskiren
6)Pregnancy or Breastfeeding
7)Inability to obtain informed consent
8)Any conditions not suitable for the participation in this trial judged by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Fukuda |
Organization
Keio University School of Medicine
Division name
Division of Cardiology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
03-5843-6702
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Matsuhashi, Motoaki Sano |
Organization
Keio University School of Medicine
Division name
Division of Cardiology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku, Tokyo, Japan
TEL
03-5843-6702
Homepage URL
Sponsor or person
Institute
Division of Cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2011 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007130
