UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001179 |
|---|---|
| Receipt number | R000001443 |
| Scientific Title | Endothelial Function in Subjects with Isolated Low HDL Cholesterol: Role of Nitric Oxide and Endothelial Progenitor Cells |
| Date of disclosure of the study information | 2008/06/10 |
| Last modified on | 2021/07/02 13:35:49 |
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Basic information
Public title
Endothelial Function in Subjects with Isolated Low HDL Cholesterol: Role of Nitric Oxide and Endothelial Progenitor Cells
Acronym
Low HDL Study
Scientific Title
Endothelial Function in Subjects with Isolated Low HDL Cholesterol: Role of Nitric Oxide and Endothelial Progenitor Cells
Scientific Title:Acronym
Low HDL Study
Region
| Japan |
Condition
Condition
Subjects with isolated low HDL cholesterol
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the contribution of isolated low HDL cholesterol to endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endothelial function (FMD)
Key secondary outcomes
Endothelial progenitor cell function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anti-dyslipidemic agent (pravastatin)
Interventions/Control_2
placebo
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects with isolated HDL cholesterol
Key exclusion criteria
Subjects with low HDL cholesterol who had other cardiovascular risk factors such as elevated levels of blood pressure, cholesterol, glucose and smoking habit
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University
Division name
Graduate School of Biomedical Sciences
Zip code
Address
1-2-3 Kasumi, Mimami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5122
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihito Hiagshi |
Organization
Hiroshima University
Division name
Graduate School of Biomedical Sciences
Zip code
Address
1-2-3 Kasumi, Mimami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5122
Homepage URL
http://home.hiroshima-u.ac.jp/angio
yhigashi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Physiology and Medicine, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
| 2008 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001443
