Study of ONO-1101 in Patients Scheduled for Coronary Angiography

Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: ONO-1101; Drug: ONO-1101; Drug: ONO-1101

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Kinki, Japan
    • Kinki region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: P	Drug: ONO-1101; placebo for 1 minute IV; Drug: ONO-1101; 0.06 mg/kg for 1 minute IV; Drug: ONO-1101; 0.125 mg/kg for 1 minute IV
Experimental: E2	Drug: ONO-1101; placebo for 1 minute IV; Drug: ONO-1101; 0.06 mg/kg for 1 minute IV; Drug: ONO-1101; 0.125 mg/kg for 1 minute IV
Experimental: E1	Drug: ONO-1101; placebo for 1 minute IV; Drug: ONO-1101; 0.06 mg/kg for 1 minute IV; Drug: ONO-1101; 0.125 mg/kg for 1 minute IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CT image quality	one day

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	For less than one month
CT diagnostic accuracy	For less than one month

Collaborators and Investigators

• Sponsor: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Shinichi Kikawa, Ono Pharmaceutial Co., Ltd

Publications and helpful links

General Publications

• Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S. A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting beta1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease. Int J Cardiovasc Imaging. 2013 Jun;29 Suppl 1(Suppl 1):7-20. doi: 10.1007/s10554-013-0253-3. Epub 2013 Jun 20.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 16, 2007
• First Submitted That Met QC Criteria: November 16, 2007
• First Posted (Estimate): November 19, 2007

Study Record Updates

• Last Update Posted (Estimate): June 13, 2012
• Last Update Submitted That Met QC Criteria: June 12, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; ONO-1101; Multi-slice CT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Landiolol
• Other Study ID Numbers: ONO-1101-26