UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003707 |
|---|---|
| Receipt number | R000004470 |
| Scientific Title | The effects of transdemal glycerol trinitrate administration on the ischemic limb for vascular intermittent claudication |
| Date of disclosure of the study information | 2010/06/04 |
| Last modified on | 2011/05/26 11:18:46 |
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Basic information
Public title
The effects of transdemal glycerol trinitrate administration on the ischemic limb for vascular intermittent claudication
Acronym
Transdemal glycerol trinitrate administration on the ischemic limb
Scientific Title
The effects of transdemal glycerol trinitrate administration on the ischemic limb for vascular intermittent claudication
Scientific Title:Acronym
Transdemal glycerol trinitrate administration on the ischemic limb
Region
| Japan |
Condition
Condition
peripheral arterial disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of transdermal administration of glycerol trinitrate (GTN) tape on the calf blood flow of the ischemic limbs in 32 patients having intermittent claudication due to peripheral arterial disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
resting and post-exercise calf blood flow, pain-free and maximum exercise times
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
transdermal administration of glycerol trinitrate tape on the ischemic limbs/ on the chest
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 having intermittent claudication due to peripheral arterial disease
Key exclusion criteria
1 Patients who can not do ankle exercise
2 Patients with severe cardiac or respiratory dysfunction
3 Patients that can not be stopped oral intake and medications
4 Patients with hypersensitivity to glycerol trinitrate tape
5 Patients with history of glycerol trinitrate adverse effect
6 Patient with lower limb paralysis
7 Patients are registered in other trials
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sato |
Organization
Graduate School of Medicine Tohoku University
Division name
Division of Advanced surgical Science and Technology
Zip code
Address
1-1, Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL
022-717-7214
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sato |
Organization
Graduate School of Medicine Tohoku University
Division name
Division of Advanced surgical Science and Technology
Zip code
Address
TEL
022-717-7214
Homepage URL
attkas@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Advanced surgical Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Division of Advanced surgical Science and Technology
Organization
Division
Category of Funding Organization
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 | 06 | Month | 04 | 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
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
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 04 | Day |
Last modified on
| 2011 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004470
| 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 |
