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Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ONO-1101
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring ONO-1101, Landiolol Hydrochloride, Multi-slice CT, Coronary Artery Disease

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hokuriku Region Facility
  • Kanto Region Facility
  • Kyusyu Region Facility

Outcomes

Primary Outcome Measures

heart rate
image quality
safety

Secondary Outcome Measures

Full Information

First Posted
April 3, 2006
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00311038
Brief Title
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT
Official Title
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
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 multi-slice CT.

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, Landiolol Hydrochloride, Multi-slice CT, Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ONO-1101
Primary Outcome Measure Information:
Title
heart rate
Title
image quality
Title
safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leaders Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Hokuriku Region Facility
City
Hokuriku
Country
Japan
Facility Name
Kanto Region Facility
City
Kanto
Country
Japan
Facility Name
Kyusyu Region Facility
City
Kyusyu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT

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