Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

Ono Pharmaceutical Co., Ltd.258 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

258

Conditions

Coronary Artery Disease

Interventions

ONO-1101DRUG

Placebo for one minute IV

ONO-1101DRUG

0.125 mg/kg for one minute IV

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥ 20 years old * Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates. Exclusion Criteria: * Previous allergic reactions to contrast agent * Renal failure * Asthma

Locations (2)

Kanto Region

Kanto, Japan

Kyushu Region

Kyushu, Japan

Outcomes

Primary Outcomes

Image quality

Time frame: one day

Secondary Outcomes

Heart rate

Time frame: 5 days maximum

Data from ClinicalTrials.gov

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