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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002566
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003128

Research Plan
Registered date File name

Research case data specifications
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Research case data
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