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

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ClinicalTrials.gov Identifier: NCT00924586
Recruitment Status : Completed
First Posted : June 19, 2009
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 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 Phase 3

Study Type : Interventional  (Clinical Trial)
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 : June 2009
Primary Completion Date : February 2010

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

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

Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 5 days maximum ]

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 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

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 ClinicalTrials.gov identifier (NCT number): NCT00924586

Kanto Region
Kanto, Japan
Kyushu Region
Kyushu, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Study Director: Mitsunobu Tanimoto Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00924586     History of Changes
Other Study ID Numbers: ONO-1101-27
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

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