UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000340 |
|---|---|
| Receipt number | R000000439 |
| Scientific Title | Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension |
| Date of disclosure of the study information | 2006/03/01 |
| Last modified on | 2017/03/08 12:42:38 |
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Basic information
Public title
Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension
Acronym
Effects of sildenafil on pulmonary arterial hypertension
Scientific Title
Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension
Scientific Title:Acronym
Effects of sildenafil on pulmonary arterial hypertension
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove hemodynamic effects and safety of sildenafil in patients with pulmonary arterial hypertention
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Decrease in pulmonary arterial pressure, pulmonary vascular resistance and increase in cardiac output at 24 weeks after allocation of patients
Key secondary outcomes
Improvement of exercise tolerance
(anaerobic threshold and peak VO2) assessed by cardiopulmonary exercise testing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with sildenafil 25mg three times daily for 24 weeks
Interventions/Control_2
Treatment with prior therapy without sildenafil for 24 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with pulmonary arterial hypertension
2. Patients in WHO functional class II-IV and with estimated right ventricular systolic pressure (transtricuspid valve pressure gradient+10)>40mmHg under prior therapy
3. Patients with informed concent
Key exclusion criteria
1. Patients with PCWP>15mmHg
2. Pregnat women or women of childbearing potential or brestfeeding
3. Patients who are being treated with medicines that contain nitrates
4. Patients who are being treated with phosphodiesterase inhibitors other than sildenafil
5. Patients who are otherwise judged inappropriate for inclusion in the study by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Yao |
Organization
The University of Tokyo Hospital
Division name
Division of cardiovascular internal medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan
TEL
03-3815-5411(33076)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Yao |
Organization
The University of Tokyo Hospital
Division name
Division of cardiovascular internal medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan
TEL
03-3815-5411(33076)
Homepage URL
YAOA-INT@h.u-tokyo.ac.jp
Sponsor or person
Institute
Division of cardiovascular internal medicine, The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of cardiovascular internal medicine, The University of Tokyo Hospital
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
| 2006 | Year | 03 | Month | 01 | 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
| 2006 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
