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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014161
Receipt No. R000016494
Scientific Title Inhibitory efficacy in platelet aggregation and pharmacokinetics of single oral administration of 300mg clopidogrel and 20mg prasugrel
Date of disclosure of the study information 2014/08/01
Last modified on 2015/05/07

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Basic information
Public title Inhibitory efficacy in platelet aggregation and pharmacokinetics of single oral administration of 300mg clopidogrel and 20mg prasugrel
Acronym Inhibitory efficacy in platelet aggregation and pharmacokinetics of clopidogrel and prasugrel
Scientific Title Inhibitory efficacy in platelet aggregation and pharmacokinetics of single oral administration of 300mg clopidogrel and 20mg prasugrel
Scientific Title:Acronym Inhibitory efficacy in platelet aggregation and pharmacokinetics of clopidogrel and prasugrel
Region
Japan

Condition
Condition Ischemic heart diseases with PIC
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Primary objective
Investigation for inhibitory efficacy in platelet aggregation of 300mg clopidogrel and 20mg prasugrel in Japanese male healthy adult subjects.

Secondary objective
Investigation for pharmacokinetics of 300mg clopidogrel and 20mg prasugrel in Japanese male healthy adult subjects.
Investigation for influence of CYP2C19 polymorphism in inhibitory efficacy in platelet aggregation and pharmacokinetics of 300mg clopidogrel and 20mg prasugrel in Japanese male healthy adult subjects.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacodynamics of clopidogrel and prasugrel
Key secondary outcomes Pharmacokinetics of clopidogrel and prasugrel

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 prasugrel
Interventions/Control_2 clopidogrel
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
45 years-old >
Gender Male and Female
Key inclusion criteria 1.Japanese
2.From 20 years old to 45 years old at voluntary written consent
3.From 50.0 kg to 85.0 kg and from 18.5 to 25.0 of BMI at screening
4.Voluntary written consent by themselves is given before screening
Key exclusion criteria 1.History of liver diseases, cardiovascular diseases, respiratory diseaases, gastroenteric diseases, kidney diseases, cerebralvascular diseases, cancer
2.Known hypersensitivity to some drugs and foods
3.Under normal range in platelet counts at screning
4.Treatment by other doctors (included supplement) within 14 days before screening
5.Treatment with any investigational compound within 120 days before screening
6.History of blood taken
*>= 1200ml of all blood within 1 year before screening
*>= 400ml of all blood with 84 days before screening
*>= 200ml of all blood within 14 days before screening
7.Known active chronic hepatitis B or C, active syphilis and human immunodeficiency virus infection
8.Abuse of alcohol or drugs (included past history)
9.Bleeding, in the tendency to bleeding, and family history and past history of bleeding disorders
10.During pregnancy and possibility of pregnancy and lactation period
11.Any serious medical or psychiatric illness that could, in the opinion of the investigator, potentially interfere with the completion of treatment according to this protocol.
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kazuo Umemura
Organization Center for clinical research,
Hamamatsu University hospital
Division name Translational center
Zip code
Address 1-20-1, Hnadayama, Higashi-ku, 431-31-92, Japan
TEL 053-435-2006
Email umemura@hama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name kazuo umemura
Organization Center for clinical research, Hamamatsu University hoapital
Division name Translational center
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hmamatsu
TEL 053-435-2006
Homepage URL
Email umemura@hama-med.ac.jp

Sponsor
Institute Kazuo Umemura
Center for clinical research
Hamamatsu University Hospital
Institute
Department

Funding Source
Organization DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization Profit 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 浜松医大附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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
2014 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 05 Month 08 Day
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 04 Day
Last modified on
2015 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016494

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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