UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2019/09/23 (Ver. 8) |
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| Basic information | ||
| Public title | Plant sterol levels during
cholesterol-lowering therapy |
|
| Acronym | Plant sterol levels during
cholesterol-lowering therapy |
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| Scientific Title | Plant sterol levels during
cholesterol-lowering therapy |
|
| Scientific Title:Acronym | Plant sterol levels during
cholesterol-lowering therapy |
|
| Region |
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| Condition | ||
| Condition | Cornary Heart Dsease
with Hyperlipidemia |
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| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 100 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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 |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | Parts of study results were presented in JCS2012 and EAS2012. |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002004 |
