UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008309 |
|---|---|
| Receipt number | R000009786 |
| Scientific Title | Subanalysis of the Impact of OLmesartan on theprogression of coronary atherosclerosis: evaluation by IntraVascular UltraSound (OLIVUS) trial |
| Date of disclosure of the study information | 2012/06/30 |
| Last modified on | 2012/06/30 12:20:09 |
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Basic information
Public title
Subanalysis of the Impact of OLmesartan on theprogression of coronary atherosclerosis: evaluation by IntraVascular UltraSound (OLIVUS) trial
Acronym
the OLIVUS-Biomarker study
Scientific Title
Subanalysis of the Impact of OLmesartan on theprogression of coronary atherosclerosis: evaluation by IntraVascular UltraSound (OLIVUS) trial
Scientific Title:Acronym
the OLIVUS-Biomarker study
Region
| Japan |
Condition
Condition
Patients with stable angina pectoris and hypertension scheduled for PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of olmesartan on serum biomarkers and the relationship between any biomarker changes and the favorable effect of olmesartan on atheroma progression in the principal study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Chanegin serum biomarkers and the relationship between any biomarker changes and the favorable effect of olmesartan on atheroma progression
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olmesartan treatment after PCI
Interventions/Control_2
medications except for olmesartan after PCI
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with clinically stable angina pectoris and hypertension scheduled for PCI
Key exclusion criteria
Patinets have complicated lesions (such as excessive tortuosity or calcified lesions, or lesions that could not be cross-sectioned using IVUS), chronic renal failure (serum creatinine >1.5), recent myocardial infarction (within 4 weeks), or poor ejection fraction (<25%); or if they were taking an angiotensin-converting enzyme (ACE) inhibitor or ARB.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikata-cho, Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
torumiyoshi@hotmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 30 | 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
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 06 | Month | 30 | Day |
Last modified on
| 2012 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009786
