UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005803 |
|---|---|
| Receipt number | R000006867 |
| Scientific Title | Long-term outcome of first-line sildenafil monotreatment for pulmonary arterial hypertension |
| Date of disclosure of the study information | 2011/06/19 |
| Last modified on | 2011/06/19 20:07:20 |
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Basic information
Public title
Long-term outcome of first-line sildenafil monotreatment for pulmonary arterial hypertension
Acronym
Sildenafil as a first-line therapy for PAH
Scientific Title
Long-term outcome of first-line sildenafil monotreatment for pulmonary arterial hypertension
Scientific Title:Acronym
Sildenafil as a first-line therapy for PAH
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term outcome of sildenafil treatment as a first-line therapy in patients with pulmonary arterial hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic parameters obtained by right-side heart catheterization, six minutes walk distance, serum BNP level, the occurrence of events such as the addition of epoprostenol, hospitalization for right-side heart failure, and survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
pulmonary arterial hypertension
Key exclusion criteria
Eisenmenger syndrome
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Satoh |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyorin University School of Medicine
Division name
Second Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
ryoji@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2011 | Year | 06 | Month | 19 | 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
| 2003 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | 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
This study demonstrated the clinical efficacy of first-line sildenafil therapy during a long-term observation period. In particular, this study clarified the relations between first-line sildenafil therapy and the occurrence of clinical events, suggesting that sildenafil is a promising therapeutic strategy as a first-line drug for the treatment of pulmonary arterial hypertension.
Management information
Registered date
| 2011 | Year | 06 | Month | 19 | Day |
Last modified on
| 2011 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006867
| 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 |
