UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000028
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute The Department of Cardiology, Nagoya University Graduate School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.