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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003346
Receipt No. R000002004
Scientific Title Plant sterol levels during cholesterol-lowering therapy
Date of disclosure of the study information 2010/03/17
Last modified on 2019/03/24

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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
Email 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
Email kajinami@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Department of Cardiology
Institute
Department

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
Email 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 No longer recruiting
Date of protocol fixation
2008 Year 12 Month 10 Day
Date of IRB
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 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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