UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062683 |
|---|---|
| Receipt number | R000071770 |
| Scientific Title | Pharmacokinetic Determinants of Clazosentan for Safe Individualized Dosing in Patients with Aneurysmal Subarachnoid Hemorrhage: Evaluation of OATP Activity Based on Genotype and Phenotype |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/25 17:38:30 |
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Basic information
Public title
Study of Safe Use of Clazosentan in Patients with Aneurysmal Subarachnoid Hemorrhage
Acronym
Clazosentan Individualized Dosing Study
Scientific Title
Pharmacokinetic Determinants of Clazosentan for Safe Individualized Dosing in Patients with Aneurysmal Subarachnoid Hemorrhage: Evaluation of OATP Activity Based on Genotype and Phenotype
Scientific Title:Acronym
CLZ-PK-OATP Study
Region
| Japan |
Condition
Condition
Subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the association between OATP activity and interindividual variability in clazosentan pharmacokinetics, and to investigate the association between pharmacokinetic variability and fluid retention-related adverse events.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic parameters of clazosentan
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with subarachnoid hemorrhage due to a ruptured brain aneurysm who underwent surgery and were newly initiated on clazosentan therapy at the Department of Neurosurgery, Shizuoka General Hospital.
2.Patients (or their legally acceptable representatives/surrogates) who have provided written informed consent to participate in this study.
Key exclusion criteria
1.Pregnant women or women who may be pregnant
2.Patients with ongoing intracranial hemorrhage
3.Patients with severe hepatic impairment (Child-Pugh Class C)
4.Patients who have received rifampicin within the past 14 days or are currently receiving rifampicin
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tasuku |
| Middle name | |
| Last name | Yokoyama |
Organization
University of Shizuok
Division name
Laboratory of Clinical Pharmaceutics, School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5857
tyokoyama@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Tasuku |
| Middle name | |
| Last name | Yokoyama |
Organization
University of Shizuoka
Division name
Laboratory of Clinical Pharmaceutics, School of Pharmaceutical Sciences
Zip code
422-8526
Address
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL
+81-54-264-5857
Homepage URL
tyokoyama@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka general hospital
Address
4-27-1, Kitaando, Aoi-ku, Shizuoka, Japan
Tel
054-247-6111
chiken-sougou@shizuoka-pho.jp
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
| 2026 | Year | 08 | Month | 25 | 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
| 2026 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted as a joint research project between the Department of Neurosurgery at Shizuoka General Hospital and the School of Pharmaceutical Sciences at University of Shizuoka, with approval from the Institutional Review Board (IRB) of both institutions.
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071770
