UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000028 |
|---|---|
| Receipt number | R000000044 |
| Scientific Title | (Olmesartan and Valsartan Anti-atherosclerosis Trial in Patients with Mild-Hypertension: Using Three-dimensional serial IVUS)Study |
| Date of disclosure of the study information | 2006/04/01 |
| Last modified on | 2013/03/19 13:37:39 |
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Basic information
Public title
(Olmesartan and Valsartan Anti-atherosclerosis Trial in Patients with Mild-Hypertension: Using Three-dimensional serial IVUS)Study
Acronym
OVATION Study
Scientific Title
(Olmesartan and Valsartan Anti-atherosclerosis Trial in Patients with Mild-Hypertension: Using Three-dimensional serial IVUS)Study
Scientific Title:Acronym
OVATION Study
Region
| Japan |
Condition
Condition
stable angina pectoris with mild hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By using three-dimensional (3D) intravascular ultrasound (IVUS), we assess if long-term olmesartan therapy just after percutaneous coronary intervention reduces coronary plaques in patients with stable angina pectoris with mild hypertension, compared with valsartan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nominal changes in % plaque volumes by three-dimensional intravascular ultrasound at 6-8 months follow-up after percutaneous coronary intervention
Key secondary outcomes
(IMT)
change from baseline in mean IMT after 6-8 months
(E/A)
change from baseline in E/A after 6-8 months by echocardiography
(laboratory test)
hs-CRP, adiponectine, aldosterone, renin, oxLDL, HOMA-R, TC, TG, LDL-C, HDL-C, etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
1) Olmesartan
Interventions/Control_2
2) Valsartan
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 mild hypertension, who have been treated with statins more than 8 weeks before the randomization
Key exclusion criteria
(non-lesion related items)
1)Patients with acute coronary syndrome
2)Previous history of Q myocardial infarction within 4 weeks before the randomization
3)Low left ventricular(LV) function(LV ejection fraction < 45%)
4)Patients with renal failure(serum creatinine > 3.0mg)
5)Patients who are treated with angiotensin converting enzyme inhibitor or receptor blocker, or aldosterone receptor blocker at randomization
(lesion related items)
1)chronic total coronary artery occlusion
2)lesions on bypass grafts
3)unsuccessful stent implantation (stenosis > 50% after PCI)
4)lesions with prior atheroablative procedures before stent implantation
5)lesions implanted with multiple stents
6)left main trunk lesions
7)lesions on small vessels(reference diameter < 2.0 mm)
8)calcified lesions, which preclude accurate quantification of IVUS imaging
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoaki Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
The Department of Cardiology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Ishii |
Organization
Nagoya University Graduate School of Medicine
Division name
The Department of Cardiology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Department of Cardiology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 04 | 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
| 2005 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 07 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000044
| 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 |
