Study of ONO-1101 in Patients Scheduled for Coronary Angiography

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: ONO-1101

• Registration Number: NCT00560209
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Primary Completion: 2008-11
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Read More

Exclusion Criteria

• Previous allergic reactions to contrast agent
• Renal failure
• Asthma
• Concomitant beta-receptor blocking agent

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	ONO-1101	-
E2	ONO-1101	-
E1	ONO-1101	-

Primary Outcome Measures

Name	Time	Method
CT image quality	one day

Secondary Outcome Measures

Name	Time	Method
Heart rate	For less than one month
CT diagnostic accuracy	For less than one month

Trial Locations

Locations (1)

Kinki Region; 🇯🇵 Kinki, Japan