Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT
June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hokuriku, Japan
- Hokuriku Region Facility
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Kanto, Japan
- Kanto Region Facility
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Kyusyu, Japan
- Kyusyu Region Facility
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20-74 years old
- Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room
Exclusion Criteria:
- Previous allergic reactions to contrast agent
- Renal failure
- Asthma
- Other exclusion criteria as specified in the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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safety
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heart rate
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image quality
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Project Leaders Development Planning, Ono Pharmaceutical Co. Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Study Registration Dates
First Submitted
April 3, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 5, 2006
Study Record Updates
Last Update Posted (Estimate)
June 13, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Landiolol
Other Study ID Numbers
- ONO-1101-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.