UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003668 |
|---|---|
| Receipt number | R000004441 |
| Scientific Title | The influence of coadministration of PPIs on pharmacodynamics of clopidogrel |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2020/12/04 14:42:34 |
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Basic information
Public title
The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Acronym
The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Scientific Title
The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Scientific Title:Acronym
The influence of coadministration of PPIs on pharmacodynamics of clopidogrel
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine the influence of coadministration of PPI (rabeprazole or omeprazole) on the effectiveness of clopidogrel by measuring platelet aggregation.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Platelet aggregation rate after intake of omeprazole or rabeprazole for 14 days
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
After administration of ranitidine 300mg for 14 days, patients receive omeprazole 20mg for 14 days, and then receive ranitidine 300mg for 14 days again. Finally they receive rabeprazole 10mg for 14 days.
Interventions/Control_2
After administration of ranitidine 300mg for 14 days, patients receive rabeprazole 10mg for 14 days, and then receive ranitidine 300mg for 14 days again. Finally they receive omeprazole 20mg for 14 days.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are taking clopidogrel and aspirin, and have reflux esophagitis.
Key exclusion criteria
Drug allergy of study drugs; aspirin, clopidogrel, omeprazole, rabeprazole and ranitidine.
Severe chronic renal failure
Severe liver dysfunction
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kyoichi |
| Middle name | |
| Last name | Mizuno |
Organization
Nippon Medical School
Department of Internal Medicine
Division name
Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Zip code
113-8603
Address
1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
sigenobu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Shigenobu |
| Middle name | |
| Last name | Inami |
Organization
Nippon Medical School Department of Internal Medicine
Division name
Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Zip code
113-8603
Address
1-1-5 Sendagi Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
sigenobu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Division of Cardiology, Hepatology, Geriatrics and Integrated Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co.,LTD.
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
Nippon Medical School Center for clinical research
Address
1-1-5 Sendagi Bunkyo-ku, Tokyo
Tel
03-3822-2131
inq-ccr@nms.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
| 2010 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 16 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004441
| Research Plan | |
|---|---|
| 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 |
