UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003107 |
|---|---|
| Receipt number | R000003771 |
| Scientific Title | Clinical efficacy of sildenafil on pulmonary hypertension in patinets with chronic respiratory disorders |
| Date of disclosure of the study information | 2010/01/27 |
| Last modified on | 2020/08/04 22:51:46 |
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Basic information
Public title
Clinical efficacy of sildenafil on pulmonary hypertension in patinets with chronic respiratory disorders
Acronym
Efficacy of sildenafil on pulmonary hypertension in respiratory disorders
Scientific Title
Clinical efficacy of sildenafil on pulmonary hypertension in patinets with chronic respiratory disorders
Scientific Title:Acronym
Efficacy of sildenafil on pulmonary hypertension in respiratory disorders
Region
| Japan |
Condition
Condition
Chronic respiratory diseases,
Chronic obstructive pulmonary disease (COPD), Chronic respiratory failure
pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy of sildenafil on pulmonary hypertension in chronic respiratory disorders in terms of physiologic aspects and quality of life
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiac function, circulatory dynamics, exercise capacity, quality of life
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sildenafil
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic respiratory disorders
pulmonary hypertension
Key exclusion criteria
1) Patients under treatment of radiotherapy and immunosuppressant at present
2) Patients who have serious acute diseases obviously
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Teramoto |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
193-0998
Address
3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
042-491-2111
shinjit-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Teramoto |
Organization
National Hospital Organization, Tokyo National Hospital
Division name
Department of Pulmonary Medicine
Zip code
193-0998
Address
National Hospital Organization, Tokyo National Hospital
TEL
042-491-2111
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization, Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Healthy, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NHO Tokyo national hispital
Address
3-1-1 Tateoka Kiyose-shi Tokyo
Tel
042-491-2111
shinjit-tky@umin.ac.jp
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 | 01 | Month | 27 | 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
| 2010 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003771
