Study of ONO-1101 in Patients Scheduled for Coronary Angiography
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-1101
ONO-1101
ONO-1101
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring ONO-1101, Coronary Artery Disease, Multi-slice CT
Eligibility Criteria
Inclusion Criteria:
- 20 years of age or older
- Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room
Exclusion Criteria:
- Previous allergic reactions to contrast agent
- Renal failure
- Asthma
- Concomitant beta-receptor blocking agent
Sites / Locations
- Kinki Region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
P
E2
E1
Arm Description
Outcomes
Primary Outcome Measures
CT image quality
Secondary Outcome Measures
Heart rate
CT diagnostic accuracy
Full Information
NCT ID
NCT00560209
First Posted
November 16, 2007
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00560209
Brief Title
Study of ONO-1101 in Patients Scheduled for Coronary Angiography
Official Title
Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
ONO-1101, Coronary Artery Disease, Multi-slice CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
183 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E2
Arm Type
Experimental
Arm Title
E1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-1101
Intervention Description
placebo for 1 minute IV
Intervention Type
Drug
Intervention Name(s)
ONO-1101
Intervention Description
0.06 mg/kg for 1 minute IV
Intervention Type
Drug
Intervention Name(s)
ONO-1101
Intervention Description
0.125 mg/kg for 1 minute IV
Primary Outcome Measure Information:
Title
CT image quality
Time Frame
one day
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
For less than one month
Title
CT diagnostic accuracy
Time Frame
For less than one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20 years of age or older
Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room
Exclusion Criteria:
Previous allergic reactions to contrast agent
Renal failure
Asthma
Concomitant beta-receptor blocking agent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichi Kikawa
Organizational Affiliation
Ono Pharmaceutial Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Kinki Region
City
Kinki
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
23784548
Citation
Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S. A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting beta1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease. Int J Cardiovasc Imaging. 2013 Jun;29 Suppl 1(Suppl 1):7-20. doi: 10.1007/s10554-013-0253-3. Epub 2013 Jun 20.
Results Reference
derived
Learn more about this trial
Study of ONO-1101 in Patients Scheduled for Coronary Angiography
We'll reach out to this number within 24 hrs