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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000023699
Receipt No. R000027292
Scientific Title Pharmakocinetics of landiolol in patients undergoing cardiac surgery
Date of disclosure of the study information 2016/08/25
Last modified on 2018/08/21

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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
Middle name
Last name Takayuki Kunisawa
Organization Asahikawa Medical University
Division name Anesthesiology and CCM
Zip code
Address 2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
TEL 81-166-68-2580
Email taka.kunisawa@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Kunisawa
Organization Asahikawa Medical University
Division name Anesthesiology and CCM
Zip code
Address 2-1-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido
TEL 0166-68-2580
Homepage URL
Email taka.kunisawa@nifty.ne.jp

Sponsor
Institute Department of Anesthesiology and CCM, Asahikawa Medical University
Institute
Department

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
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
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
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 Suspended
Date of protocol fixation
2014 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 26 Day
Last follow-up date
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
2018 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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