UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002566 |
|---|---|
| Receipt number | R000003128 |
| Scientific Title | THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2016/05/17 02:24:18 |
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Basic information
Public title
THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS
Acronym
THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS
Scientific Title
THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS
Scientific Title:Acronym
THE POSSIBILITY FOR AVOIDANCE OF MUTUAL PHARMACOKINETIC INTERACTION BETWEEN SILDENAFIL AND BOSENTAN, STAGGERING ADMINISTRATION TIMING OF THE TWO DRUGS
Region
| Japan |
Condition
Condition
Pulmonary Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension (PH) is a rare, but intractable and lethal disease. Now there are some pharmacological treatments, including bosentan, the endothelin receptor antagonist (ERA), and sildenafil, the phosphodiesterase-5 (PDE5) inhibitor. These drugs are actually used in combination in clinical practice, but there is an article reported in 2005 which concludes that bosentan significantly decreases the plasma concentration of sildenafil when coadministered to patients with pulmonary hypertension. This can be a significant problem in the treatment of this disease.
In practice, sildenafil is taken three times a day while bosentan is taken twice a day, which makes these two drugs taken at the same time in the morning and in the evening. Sildenafil reaches its Cmax only one hour after medication and its half-life period is about three hours, while bosentan reaches its Cmax three hours after medication and its half-life period is about four hours.
Considering these pharmacokinetic differences of the two drugs, we hypothesize that it is possible to avoid suppressing plasma concentration of sildenafil even in combination use with bosentan if only the timing of one drug is staggered from the other.
The aim of this study is to investigate the change of plasma concentration of sildenafil and bosentan between simultaneous administration and staggering administration in PH patients who now use both drugs.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Plasma cancentration of sildenafil and its primary metabolite N-desmethylsildenafil of the following blood samples;
before dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h post dose of the first sildenafil on the day.
Key secondary outcomes
# Plasma concentration of Bosentan of the same points above.
# Blood pressure of before dose, 1 and 3 h post dose of the first sildenafil on the day.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
<Intervention 1> C, A, C, B
A: Bosentan administration three hours after sildenafil; seven days
B: Sildenafil administration three hours after bosentan; seven days
C: Simultaneous administration of sildenafil and bosentan; seven days
Interventions/Control_2
<Intervention 2> C, B, C, A
A: Bosentan administration three hours after sildenafil; seven days
B: Sildenafil administration three hours after bosentan; seven days
C: Simultaneous administration of sildenafil and bosentan; seven days
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
1 Patients of pulmonary hypertention of WHO performance classfication 3 and 4.
2 Patients who continuously take both bosentan and sildenafil.
Key exclusion criteria
1 Patients who entail obvious adverse side-effects of either bosentan or sildenafil.
2 Patients who hardly continue taking bosentan or sildenafil for other reasons.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Watanabe |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka
TEL
053-435-2385
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Miyakawa |
Organization
Hamamatsu University School of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
Address
TEL
053-435-2385
Homepage URL
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
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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2001 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 30 | Day |
Last modified on
| 2016 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003128
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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