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
  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:


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
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, see Learn About Clinical Studies.

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 by Ono Pharmaceutical Co. Ltd

Additional 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
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 July 26, 2014