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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00311038
First received: April 3, 2006
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00311038     History of Changes
Other Study ID Numbers: ONO-1101-24
Study First Received: April 3, 2006
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013