Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT

• Sponsor: Ono Pharmaceutical Co. Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00311038
• Collaborator: (none)
• Enrollment: 90
• Locations: 3
• Patients Per Site: 30

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease
• Study Start Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

1. heart rate []

2. image quality []

3. safety []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 20-74 years old

2. Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

1. Previous allergic reactions to contrast agent

2. Renal failure

3. Asthma

4. Other exclusion criteria as specified in the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hokuriku Region Facility	Hokuriku		Japan
2	Kanto Region Facility	Kanto		Japan
3	Kyusyu Region Facility	Kyusyu		Japan

Sponsors and Collaborators

• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Project Leaders Development Planning, Ono Pharmaceutical Co. Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ono Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT00311038
• Other Study ID Numbers: ONO-1101-24
• First Posted: Apr 5, 2006
• Last Update Posted: Jun 13, 2012
• Last Verified: Jun 1, 2012

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

Study Results

No Results Posted as of Jun 13, 2012