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

Phase 3

Completed

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

• Registration Number: NCT00924586
• 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 multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Primary Completion: 2010-02
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E	ONO-1101	-
P	ONO-1101	-

Primary Outcome Measures

Name	Time	Method
Image quality	one day

Secondary Outcome Measures

Name	Time	Method
Heart rate	5 days maximum

Trial Locations

Locations (2)

Kanto Region; 🇯🇵 Kanto, Japan

Kyushu Region; 🇯🇵 Kyushu, Japan