UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032844 |
|---|---|
| Receipt number | R000037458 |
| Scientific Title | Efficacy of Evolocumab in patients with arteriosclerosis obliterans. |
| Date of disclosure of the study information | 2018/06/02 |
| Last modified on | 2018/06/02 11:07:59 |
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Basic information
Public title
Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Acronym
Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Scientific Title
Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Scientific Title:Acronym
Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Region
| Japan |
Condition
Condition
arteriosclerosis obliterans
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficay of evolocumab in patients with arteriosclerosis obliterans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the ratio of lower limb amputation after 48 weels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
evolocumab140mg/2weeks for 48 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with arteriosclerosis obliterans
having
-Dyslipidemia undergoing treatment with HMG-CoA reductase inhibition
-LDL-C 100 mg/dL or more in conventional therapy
Key exclusion criteria
-HMG-CoA reductase inhibitor is not used at the time of introduction
-At the time of introduction of research drugs, patients with LDL-C less than 100 mg / dL
-Contraindicated patients with HMG-CoA reductase inhibitors
-Hypersensitivity to the study drug
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Uzui |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8800
huzui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Uzui |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8800
Homepage URL
huzui@u-fukui.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2018 | Year | 06 | Month | 02 | 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
| 2018 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | 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
| 2018 | Year | 06 | Month | 02 | Day |
Last modified on
| 2018 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037458
| 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 |
