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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00924586
First Posted: June 19, 2009
Last Update Posted: June 13, 2012
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.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  Purpose
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 Intervention Phase
Coronary Artery Disease Drug: ONO-1101 Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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

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

Enrollment: 258
Study Start Date: June 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P Drug: ONO-1101
Placebo for one minute IV
Experimental: E Drug: ONO-1101
0.125 mg/kg for one minute IV

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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


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

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00924586     History of Changes
Other Study ID Numbers: ONO-1101-27
First Submitted: June 18, 2009
First Posted: June 19, 2009
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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Landiolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents


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