UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003346 |
|---|---|
| Receipt number | R000002004 |
| Scientific Title | Plant sterol levels during cholesterol-lowering therapy |
| Date of disclosure of the study information | 2010/03/17 |
| Last modified on | 2019/09/23 13:30:04 |
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Basic information
Public title
Plant sterol levels during
cholesterol-lowering therapy
Acronym
Plant sterol levels during
cholesterol-lowering therapy
Scientific Title
Plant sterol levels during
cholesterol-lowering therapy
Scientific Title:Acronym
Plant sterol levels during
cholesterol-lowering therapy
Region
| Japan |
Condition
Condition
Cornary Heart Dsease
with Hyperlipidemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cholesterol metabolism in Statin mono therapy and Statin+Ezetimibe combination therapy is clarified.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum lipid levels
inflammatory markers
choresterol synthesis/absoption
markers
Key secondary outcomes
Clinical laboratory test results
Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Statin high dose mono therapy
Interventions/Control_2
Statin+Ezetimibe combination therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cornary Heart Dsease
with Hyperlipidemia patient who fills following criteria
nonHDL Cholesterol 130mg/dL or more
20 years or more
Key exclusion criteria
Hypersenstivity
Patient who has received it within four weeks undertaking
administering of medicine
Resin/Fibrate/Niacin/EPA/
Probucol etc
Patient who judged that examination doctor in charge is improper
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Kajinami |
Organization
Kanazawa Medical University
Division name
Department of Cardiology
Zip code
9200293
Address
1-1 Daigaku,Uchinada,Kahoku,Ishikawa
TEL
076-286-2211
kajinami@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Kajinami |
Organization
Kanazawa Medical University
Division name
Department of Cardiology
Zip code
9200293
Address
1-1 Daigaku,Uchinada,Kahoku,Ishikawa
TEL
076-286-2211
Homepage URL
kajinami@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Kanazawa Medical 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
Clinical trial management
Address
1-1 Daigaku,Uchinada,Kahoku,Ishikawa
Tel
076-286-2211
tiken@kanazawa-med.ac.jp
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
金沢医科大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In ezetimibe combination group, LDLC lowering respnoses were associated with the levels of cholesterol absorption markers before randomization. Contraly, those were associated with the level of cholesterol synthesis marker in atrovastatin doubling group.
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
| 2008 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2009 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Parts of study results were presented in JCS2012 and EAS2012.
Management information
Registered date
| 2010 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002004
