Study of ONO-1101 in Patients Scheduled for Coronary Angiography

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00560209
• Collaborator: (none)
• Enrollment: 183
• Location: 1
• Arms: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: ONO-1101; Drug: ONO-1101; Drug: ONO-1101	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P	Drug: ONO-1101; placebo for 1 minute IV
Experimental: E2	Drug: ONO-1101; 0.125 mg/kg for 1 minute IV
Experimental: E1	Drug: ONO-1101; 0.06 mg/kg for 1 minute IV

Outcome Measures

Primary Outcome Measures

1. CT image quality [one day]

Secondary Outcome Measures

1. Heart rate [For less than one month]

2. CT diagnostic accuracy [For less than one month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kinki Region	Kinki		Japan

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Shinichi Kikawa, Ono Pharmaceutial Co., Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT00560209
• Other Study ID Numbers: ONO-1101-26
• First Posted: Nov 19, 2007
• Last Update Posted: Jun 13, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Ono Pharmaceutical Co. Ltd: ONO-1101; Coronary Artery Disease; Multi-slice CT
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Landiolol

Study Results

No Results Posted as of Jun 13, 2012