UMIN-CTR Clinical Trial

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
Email

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
Email	yhigashi@hiroshima-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Physiology and Medicine, Hiroshima University Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001443