UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005464 |
|---|---|
| Receipt number | R000006480 |
| Scientific Title | Drug interactions and effects of combination therapy for pulmonary arterial hypertension |
| Date of disclosure of the study information | 2011/04/19 |
| Last modified on | 2011/04/18 23:14:14 |
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Basic information
Public title
Drug interactions and effects of combination therapy for pulmonary arterial hypertension
Acronym
Drug interactions and effects of PAH combination therapy
Scientific Title
Drug interactions and effects of combination therapy for pulmonary arterial hypertension
Scientific Title:Acronym
Drug interactions and effects of PAH combination therapy
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the drug interactions and effects of combination therapy for pulmonary arterial hypertension; sildenafil and bosentan, sildenafil and ambrisentan, and tadalafil and ambrisentan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pharmacokinetics in the last week of each phase: sildenafil, bosentan, ambrisentan and tadalafil.
Exercise tolerability test: 6 minute walk test, shattle walking test and maximal oxygen consumption test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks
Interventions/Control_2
phase 2: sildenafil(60mg/day) and
ambrisentan (5mg/day) for 4 or 5 weeks
Interventions/Control_3
phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males or females over 20 years of age with pulmonary arterial hypertension in WHO functional classes I or II.
No history of drug allergy.
No history of drug and alchohol abuse.
Written informed concent obtained.
Key exclusion criteria
Unstable disease conditions.
Disabilities of walk.
Home oxygen therapy.
Ineligible patients judged by principal. investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takeuchi |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Japan
TEL
053-435-2385
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takeuchi |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Japan
TEL
053-435-2385
Homepage URL
takeutik@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Shizuoka
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
浜松医科大学付属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 18 | Day |
Last modified on
| 2011 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006480
