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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003107
Receipt No. 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 2010/01/27

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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 No treatment
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

Not applicable
Age-upper limit

Not applicable
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
Middle name
Last name Jun-ichi Suzuki
Organization National Hospital Organization, Tokyo National Hospital
Division name Department of Pulmonary Medicine
Zip code
Address 3-1-1 Takeoka, Kiyose, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun-ichi Suzuki
Organization National Hospital Organization, Tokyo National Hospital
Division name Department of Pulmonary Medicine
Zip code
Address
TEL 042-491-2111
Homepage URL
Email shinjit-tky@umin.ac.jp

Sponsor
Institute National Hospital Organization, Tokyo National Hospital
Institute
Department

Funding Source
Organization Ministry of Healthy, Labor and Welfare of Japan
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
Email

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 Enrolling by invitation
Date of protocol fixation
2010 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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 01 Month 27 Day
Last modified on
2010 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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