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NCT00311038 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311038
Other study ID # ONO-1101-24
Secondary ID
Status Completed
Phase Phase 2
First received April 3, 2006
Last updated June 12, 2012
Start date April 2006

Study information
Verified date June 2012
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 74 Years
Eligibility Inclusion Criteria:

1. 20-74 years old

2. Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

1. Previous allergic reactions to contrast agent

2. Renal failure

3. Asthma

4. Other exclusion criteria as specified in the protocol

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-1101

Locations
Country Name City State
Japan Hokuriku Region Facility Hokuriku
Japan Kanto Region Facility Kanto
Japan Kyusyu Region Facility Kyusyu

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate
Primary image quality
Primary safety
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