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

This study has been completed.

First Received: April 3, 2006 Last Updated: September 10, 2007 History of Changes

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00311038

Purpose

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: ONO-1101	Phase II

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Ono 1101

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

heart rate
image quality
safety

Estimated Enrollment:	90
Study Start Date:	April 2006

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

20-74 years old
Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

Previous allergic reactions to contrast agent
Renal failure
Asthma
Other exclusion criteria as specified in the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311038

Locations

Japan
Kanto Region Facility
Kanto, Japan
Hokuriku Region Facility
Hokuriku, Japan
Kyusyu Region Facility
Kyusyu, Japan

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Project Leaders Development Planning

Ono Pharma

More Information

No publications provided

Study ID Numbers:	ONO-1101-24
Study First Received:	April 3, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00311038 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-1101
Landiolol Hydrochloride
Multi-slice CT
Coronary Artery Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Myocardial Ischemia
Vascular Diseases
Cardiovascular Agents
Ischemia

Arteriosclerosis
Landiolol
Coronary Disease
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Neurotransmitter Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Arteriosclerosis

Landiolol
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 07, 2009