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NCT00560209 Clinical Trial

Study of ONO-1101 in Patients Scheduled for Coronary Angiography

Coronary Artery Disease Clinical Trial

Official title:
Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00560209
Other study ID # ONO-1101-26
Secondary ID
Status Completed
Phase Phase 2
First received November 16, 2007
Last updated June 12, 2012
Start date November 2007

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 coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

Recruitment information / eligibility
Status Completed
Enrollment 183
Est. completion date
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-1101
placebo for 1 minute IV
• ONO-1101
0.06 mg/kg for 1 minute IV
• ONO-1101
0.125 mg/kg for 1 minute IV

Locations
Country Name City State
Japan Kinki Region Kinki

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 CT image quality one day No
Secondary Heart rate For less than one month No
Secondary CT diagnostic accuracy For less than one month No
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