Study of ONO-1101 in Patients Scheduled for Coronary Angiography

Ono Pharmaceutical Co., Ltd.183 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

183

Conditions

Coronary Artery Disease

Interventions

ONO-1101DRUG

placebo for 1 minute IV

ONO-1101DRUG

0.06 mg/kg for 1 minute IV

ONO-1101DRUG

0.125 mg/kg for 1 minute IV

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Kinki Region

Kinki, Japan

Outcomes

Primary Outcomes

CT image quality

Time frame: one day

Secondary Outcomes

Heart rate

Time frame: For less than one month

CT diagnostic accuracy

Time frame: For less than one month

Data from ClinicalTrials.gov

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