UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006029 |
|---|---|
| Receipt number | R000007136 |
| Scientific Title | An observational study examining endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy |
| Date of disclosure of the study information | 2011/07/23 |
| Last modified on | 2014/01/24 14:44:46 |
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Basic information
Public title
An observational study examining endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy
Acronym
Examination of endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy
Scientific Title
An observational study examining endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy
Scientific Title:Acronym
Examination of endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examinine endothelium-dependent vasodilatation before and after high-dose rosuvastatin therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelium-dependent vasodilatation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients with hyperlipidemia who provide written informed consent
Key exclusion criteria
1) Patients with familiar hyperlipidemia
2) Patients with rosuvastatin hypersensitivity
3) Patients with abnormal values of laboratory tests
4) Patients with kidney transplantation or dialysis
5) Patients with administration of cyclosporine
6) Pregnant women, or nursing women
7) Patients with history of hypothyroidism, hereditary myopathy, drug-induced muscle disorder or family history of hereditary myopathy
8) Patients with drug abuse, or alcoholism
9) Patients with malignant disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Internal medicine and Cardiology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka City, Osaka, Japan
TEL
06-6645-3800
yoshiyama@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Internal medicine and Cardiology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka City, Osaka, Japan
TEL
06-6645-3801
Homepage URL
yoshiyama@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Department of Internal medicine and Cardiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 07 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 03 | Month | 07 | 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
Observe changes of endothelium-dependent vasodilatation, biochemical indices and bioactive substances before and after high-dose rosuvastatin therapy and examine relations between changes of endothelium-dependent vasodilatation and those of biochemical indices or bioactive substances
Management information
Registered date
| 2011 | Year | 07 | Month | 23 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007136
