UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015077
Receipt number R000017539
Scientific Title Pharmakocinetics of landiolol in patients with peripheral arterial disease
Date of disclosure of the study information 2014/09/12
Last modified on 2014/09/06 12:31:04

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Basic information

Public title

Pharmakocinetics of landiolol in patients with peripheral arterial disease

Acronym

Pharmakocinetics of landiolol in patients with peripheral arterial disease

Scientific Title

Pharmakocinetics of landiolol in patients with peripheral arterial disease

Scientific Title:Acronym

Pharmakocinetics of landiolol in patients with peripheral arterial disease

Region

Japan


Condition

Condition

Peripheral arterial disease

Classification by specialty

Anesthesiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Pharmacokinetics of landiolol

Basic objectives2

Pharmacokinetics

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 80 kg and ASA physical status 2 or 3

Key exclusion criteria

Patients with arrhythmia and patients medicated with alpha-methyldopa, clonidine or beta-blocker

Target sample size

8


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

+81-166-68-2583

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

81-166-68-2583

Homepage URL


Email

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

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

2014 Year 09 Month 12 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

Completed

Date of protocol fixation

2007 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 11 Month 01 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

2014 Year 09 Month 06 Day

Last modified on

2014 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017539


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name