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Study of ONO-1101 in Patients Scheduled for Coronary Angiography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560209
First Posted: November 19, 2007
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 coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

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

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 Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study

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

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

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

Enrollment: 183
Study Start Date: November 2007
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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
  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): NCT00560209


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00560209     History of Changes
Other Study ID Numbers: ONO-1101-26
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-1101
Coronary Artery Disease
Multi-slice CT

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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