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Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ONO-1101
ONO-1101
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • ≥ 20 years old
  • Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.

Exclusion Criteria:

  • Previous allergic reactions to contrast agent
  • Renal failure
  • Asthma

Sites / Locations

  • Kanto Region
  • Kyushu Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

P

E

Arm Description

Outcomes

Primary Outcome Measures

Image quality

Secondary Outcome Measures

Heart rate

Full Information

First Posted
June 18, 2009
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00924586
Brief Title
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)
Official Title
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT), 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
June 2009 (undefined)
Primary Completion Date
February 2010 (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 multi-slice CT, 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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ONO-1101
Intervention Description
Placebo for one minute IV
Intervention Type
Drug
Intervention Name(s)
ONO-1101
Intervention Description
0.125 mg/kg for one minute IV
Primary Outcome Measure Information:
Title
Image quality
Time Frame
one day
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
5 days maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 20 years old Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates. Exclusion Criteria: Previous allergic reactions to contrast agent Renal failure Asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitsunobu Tanimoto
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kyushu Region
City
Kyushu
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

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