UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023699 |
|---|---|
| Receipt number | R000027292 |
| Scientific Title | Pharmakocinetics of landiolol in patients undergoing cardiac surgery |
| Date of disclosure of the study information | 2016/08/25 |
| Last modified on | 2020/02/22 16:37:50 |
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Basic information
Public title
Pharmakocinetics of landiolol in patients undergoing cardiac surgery
Acronym
Pharmakocinetics of landiolol in patients undergoing cardiac surgery
Scientific Title
Pharmakocinetics of landiolol in patients undergoing cardiac surgery
Scientific Title:Acronym
Pharmakocinetics of landiolol in patients undergoing cardiac surgery
Region
| Japan |
Condition
Condition
Cardiac disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetics of landiolol
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentration of landiolol from the start of administration until 20 min after the end of administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol was administered at target concentrations of 0.5 and 1.0 mcg/mL for each 30 min at each target concentration.
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 with body weight of less than 100 kg and ASA physical status 2 - 4
Key exclusion criteria
Patients with arrhythmia and patients medicated with alpha-methyldopa or clonidine
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kunisawa |
Organization
Asahikawa Medical University
Division name
Anesthesiology and CCM
Zip code
0788510
Address
2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
TEL
81-166-68-2580
taka.kunisawa@nifty.ne.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kunisawa |
Organization
Asahikawa Medical University
Division name
Anesthesiology and CCM
Zip code
0788510
Address
2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
TEL
0166-68-2580
Homepage URL
taka.kunisawa@nifty.ne.jp
Sponsor or person
Institute
Department of Anesthesiology and CCM, Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
Tel
0166-68-2297
rs-kk.g@asahikawa-med.ac.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
| 2016 | 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
8
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027292
