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NCT00924586 Clinical Trial

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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00924586
Other study ID # ONO-1101-27
Secondary ID
Status Completed
Phase Phase 3
First received June 18, 2009
Last updated June 12, 2012
Start date June 2009

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

Recruitment information / eligibility
Status Completed
Enrollment 258
Est. completion date
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• ONO-1101
Placebo for one minute IV
• ONO-1101
0.125 mg/kg for one minute IV

Locations
Country Name City State
Japan Kanto Region Kanto
Japan Kyushu Region Kyushu

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 Image quality one day No
Secondary Heart rate 5 days maximum Yes
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