UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Title of the study (Brief title)	Comfirmation of therapeutic drug monitoring for pulmonary hypertension
Region	Japan

Condition
Condition	pulmonary hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is the development of therapeutic drug monitoring (TDM) of PAH drugs (sildenafil, tadalafil, bosentan, macitentan, ambrisentan), and to perform population pharmacokinetic analysis.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. plasma drug concentration 2. laboratory tests 3. patients charactoristics 4. drug compliance
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients administered sildenafil, tadalafil, bosentan, ambrisentan and/or macitentan
Key exclusion criteria	patient who is decided as inadequate by doctor
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Watanabe
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapeutics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Email	hwat@hama-med.ac.jp

Public contact
Name of contact person	Akio Hakamata
Organization	Hamamatsu University School of Medicine
Division name	Department of Clinical Pharmacology and Therapeutics
Address	1-20-1, Hanadayama, Higashi-ku, Hamamatsu
TEL	053-435-2385
Homepage URL
Email	hakamata@hama-med.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Parmacy Practice and Science, School of PharmaceuticalaScience, University of Shizuoka
Name of secondary funｄer(s)

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	2016 Year 06 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 09 Day
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Blood samples are taken from patients who are treated with sildenafil, tadalafil, bosentan, ambrisentan, macitentan at 1-3 points per day. Administration of drugs and laboratory tests are not changed from the needs of therapy. Plasma drug concentration, values of laboratory test, patients charactoristics and drug compliane are investigated. Pharmacokinetic analysis and evaluation of relationship between plasna concentrations and efficacy/safety are performed.

Management information
Registered date	2016 Year 06 Month 03 Day
Last modified on	2016 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026045