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

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00924586
• Collaborator: (none)
• Enrollment: 258
• Locations: 2
• Arms: 2
• Patients Per Site: 129

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 multi-slice CT, 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	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 258 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P	Drug: ONO-1101; Placebo for one minute IV
Experimental: E	Drug: ONO-1101; 0.125 mg/kg for one minute IV

Outcome Measures

Primary Outcome Measures

1. Image quality [one day]

Secondary Outcome Measures

1. Heart rate [5 days maximum]

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanto Region	Kanto		Japan
2	Kyushu Region	Kyushu		Japan

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Mitsunobu Tanimoto, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT00924586
• Other Study ID Numbers: ONO-1101-27
• First Posted: Jun 19, 2009
• Last Update Posted: Jun 13, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Coronary Artery Disease; Landiolol

Study Results

No Results Posted as of Jun 13, 2012