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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005464
Receipt No. 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

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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
Email

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
Email takeutik@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006480

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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