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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560209

Enrollment

183

Registered

2007-11-19

Start date

2007-11-30

Completion date

Unknown

Last updated

2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

ONO-1101, Coronary Artery Disease, Multi-slice CT

Brief summary

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.

Interventions

DRUGONO-1101

placebo for 1 minute IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CT image quality	one day

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026