UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014161 |
|---|---|
| Receipt number | 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 09:04:49 |
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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
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
umemura@hama-med.ac.jp
Public contact
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
umemura@hama-med.ac.jp
Sponsor or person
Institute
Kazuo Umemura
Center for clinical research
Hamamatsu University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016494
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
