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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311038
First Posted: April 5, 2006
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.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • heart rate
  • image quality
  • safety

Estimated Enrollment: 90
Study Start Date: April 2006
  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 to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20-74 years old
  2. Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

  1. Previous allergic reactions to contrast agent
  2. Renal failure
  3. Asthma
  4. Other exclusion criteria as specified in the protocol
  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): NCT00311038


Locations
Japan
Hokuriku Region Facility
Hokuriku, Japan
Kanto Region Facility
Kanto, Japan
Kyusyu Region Facility
Kyusyu, Japan
Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leaders Development Planning Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00311038     History of Changes
Other Study ID Numbers: ONO-1101-24
First Submitted: April 3, 2006
First Posted: April 5, 2006
Last Update Posted: June 13, 2012
Last Verified: June 2012

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

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