UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003994 |
|---|---|
| Receipt number | R000004735 |
| Scientific Title | Effect of Cilostazol on vascular endothelial function in type 2 diabetic patients with peripheral arterial disease |
| Date of disclosure of the study information | 2010/08/05 |
| Last modified on | 2010/07/28 21:26:59 |
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Basic information
Public title
Effect of Cilostazol on vascular endothelial function in type 2 diabetic patients with peripheral arterial disease
Acronym
Effect of Cilostazol on vascular endothelial function in type 2 diabetic patients with peripheral arterial disease
Scientific Title
Effect of Cilostazol on vascular endothelial function in type 2 diabetic patients with peripheral arterial disease
Scientific Title:Acronym
Effect of Cilostazol on vascular endothelial function in type 2 diabetic patients with peripheral arterial disease
Region
| Japan |
Condition
Condition
Type 2 diabetes
Peripheral arterial disease
Classification by specialty
| Endocrinology and Metabolism | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of Cilostazol on flow-mediated vasodilatation in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow-mediated vasodilatation
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cilostazol
50-100mg X 2 / day
24 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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetes
2. Toe brachial pressure index < 0.6
3. Written informed consent
Key exclusion criteria
1. Active bleeding or bleedind tendency
2. Congestive heart failure
3. History of hypersensitivity to Cilostazol
4. Pregnancy
5. Severe hepatic or renal dysfunction
6. Uncontrolled proliferative retinopathy
7. Malignancy
8. Patients ineligible for the study determined by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuro Miyata |
Organization
The University of Tokyo
Division name
Vascular Surgery
Zip code
Address
7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Vascular Surgery
Zip code
Address
7-3-1 Hongo, Bunkyouku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
The University of Tokyo
Vascular Surgery
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Vascular Surgery
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
| 2010 | Year | 08 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
Management information
Registered date
| 2010 | Year | 08 | Month | 04 | Day |
Last modified on
| 2010 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004735
