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Study of ONO-1101 in Patients Scheduled for Coronary Angiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00560209
First received: November 16, 2007
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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • CT image quality [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: For less than one month ] [ Designated as safety issue: No ]
  • CT diagnostic accuracy [ Time Frame: For less than one month ] [ Designated as safety issue: No ]

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

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00560209     History of Changes
Other Study ID Numbers: ONO-1101-26
Study First Received: November 16, 2007
Last Updated: June 12, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 16, 2013