UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005734 |
|---|---|
| Receipt number | R000006742 |
| Scientific Title | The effects of therapeutic agents against hypertension, dyslipidemia or diabetes on cholesterol efflux capacity by HDL cholesterol |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2017/06/11 14:36:44 |
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Basic information
Public title
The effects of therapeutic agents against hypertension, dyslipidemia or diabetes on cholesterol efflux capacity by HDL cholesterol
Acronym
The effects of therapeutic agents on cholesterol efflux capacity by HDL cholesterol
Scientific Title
The effects of therapeutic agents against hypertension, dyslipidemia or diabetes on cholesterol efflux capacity by HDL cholesterol
Scientific Title:Acronym
The effects of therapeutic agents on cholesterol efflux capacity by HDL cholesterol
Region
| Japan |
Condition
Condition
Hypertension, Dyslipidemia, Diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effects of therapeutic agents against hypertension, dyslipidemia and diabetes on cholesterol efflux capacity by HDL cholesterol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cholesterol efflux capacity by HDL cholesterol
Key secondary outcomes
pre beta-1, ApoA-I, ApoA-II, oxidative stress marker(T-BARS) etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients start to take Norvasc 5mg/day for hypertension.
Interventions/Control_2
Patients start to take Olmetec 20mg/day for hypertension.
Interventions/Control_3
Patients start to take Micardis 40mg/day
for hypertension.
Interventions/Control_4
Patients start to take Livaro 2mg/day
for dyslipidemia.
Interventions/Control_5
Patients start to take Lipitol 10mg/day
for dyslipidemia.
Interventions/Control_6
Patients start to take Crestol 5mg/day
for dyslipidemia.
Interventions/Control_7
Patients start to take Zetia 10mg/day
for dyslipidemia.
Interventions/Control_8
Patients start to take Bezatol SR 400mg/day for dyslipidemia.
Interventions/Control_9
Patients start to take Actos 30mg/day
for diabetes.
Interventions/Control_10
Patients start to take either Metfolmin 750mg/day or Voglibose 0.6mg/day for
diabetes.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed as hypertension, hypercholesteremia, hypertriglicemia, or type 2 diabetes according to their crieteria, take no medicine for each disease and consent to participate in this study
Key exclusion criteria
.Patients who have allergy for taking medicine
.Patients who have hepatic disorder(AST or ALT> 100IU/L),
biliary duct obstruction and
the following diseases with decreased hepatic function (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer and jaundice)
.eGFR<60ml/min/1.73m2
.Diabetes patients treated with insulin.
.Female patients with the possibility of pregnancy
.Patients excluded by doctors
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimura Takeshi |
Organization
Graduate school of medicine, Kyoto University
Division name
Department of Cardiovascular medicine
Zip code
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3190
kohono@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koh Ono |
Organization
Graduate school of medicine, Kyoto University
Division name
Department of Cardiovascular medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3190
Homepage URL
kohono@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Dept. of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports,
science and technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 01 | Month | 01 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | 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
| 2011 | Year | 06 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
