UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007158 |
|---|---|
| Receipt number | R000008423 |
| Scientific Title | Effect of Aliskiren on Endothelial Function in Hypertensive Patients with Ischemic Heart Disease |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2014/07/30 09:48:03 |
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Basic information
Public title
Effect of Aliskiren on Endothelial Function in Hypertensive Patients with Ischemic Heart Disease
Acronym
Aliskiren and Endothelial Function
Scientific Title
Effect of Aliskiren on Endothelial Function in Hypertensive Patients with Ischemic Heart Disease
Scientific Title:Acronym
Aliskiren and Endothelial Function
Region
| Japan |
Condition
Condition
Hypertension Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate about the effect on endothelial function of Aliskiren in addition to angiotensin II receptor blocker in patients with hypertension and ischemic heart disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
FMD
Key secondary outcomes
BP, aldosterone, CRP, urine albumine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aliskiren
Interventions/Control_2
Valsartan
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
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Hypertension
2)Ischemic heart disease
3)outpatient
Key exclusion criteria
1)the history of allergy against aliskiren
2)diabetes HbA1C 6.5%<
3)unstabel angina, recent myocardial infaction or recent cerebral infarction (within 3 months)
4)severe liver dysfunction AST(GOT) or ALT(GPT) : 100U <
5)severe renal dysfunction Cre : 2.0<
6)pregnant
7)hyperkalemia
8) the history of drug and alcohol abuse
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunobu Hirata |
Organization
Tokyo university hospital
Division name
Department of Cardiovascular medicine
Zip code
Address
Bunkyo-ku Hongo 7-3-1
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo university hospital
Division name
Department of Cardiovascular medicine
Zip code
Address
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
University of Tokyo
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
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
| 2012 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 09 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2014 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008423
