Study of ONO-1101 in Patients Scheduled for Coronary Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560209
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
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 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 Phase 2

Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : November 2008

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

Primary Outcome Measures :
  1. CT image quality [ Time Frame: one day ]

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: For less than one month ]
  2. CT diagnostic accuracy [ Time Frame: For less than one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560209

Kinki Region
Kinki, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Shinichi Kikawa Ono Pharmaceutial Co., Ltd

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00560209     History of Changes
Other Study ID Numbers: ONO-1101-26
First Posted: November 19, 2007    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
Coronary Artery Disease
Multi-slice CT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents