UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007721 |
|---|---|
| Receipt number | R000005840 |
| Scientific Title | Clinical trial of effects of isosorbide mononitrate on vascular function |
| Date of disclosure of the study information | 2012/04/11 |
| Last modified on | 2019/11/12 14:56:56 |
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Basic information
Public title
Clinical trial of effects of isosorbide mononitrate on vascular function
Acronym
Isosorbide mononitrate study
Scientific Title
Clinical trial of effects of isosorbide mononitrate on vascular function
Scientific Title:Acronym
Isosorbide mononitrate study
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the effects of isosorbide mononitrate on vascular function in patients with ischemic heart disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function (FMD), endothelial progenitor cells, Rho kinase activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Isosorbide mononitrate treatment
Interventions/Control_2
Untreated (control)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ischemic heart disease
Key exclusion criteria
Patients with cancer
Patients with stoke and/or myocardial infraction within 12 weeks of the prior to study
Patients with heart failure (≥NYHA 4)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihito Higashi |
Organization
Hiroshima University Hospital
Division name
Division of Regenerative Medicine
Zip code
Address
1-2-3 Kasumi, Mimami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5122
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihito Hiagshi |
Organization
Hiroshima University Hospital
Division name
Division of Regenerative Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2012 | Year | 04 | Month | 11 | 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
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005840
