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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
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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

First Posted
November 16, 2007
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
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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

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Study of ONO-1101 in Patients Scheduled for Coronary Angiography

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