NCT00560209

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

November 16, 2007

Last Update Submit

June 12, 2012

Conditions

Coronary Artery Disease

Keywords

ONO-1101Coronary Artery DiseaseMulti-slice CT

Outcome Measures

Primary Outcomes (1)

  • CT image quality

    one day

Secondary Outcomes (2)

  • Heart rate

    For less than one month

  • CT diagnostic accuracy

    For less than one month

Study Arms (3)

P

PLACEBO COMPARATOR
Drug: ONO-1101

E2

EXPERIMENTAL
Drug: ONO-1101

E1

EXPERIMENTAL
Drug: ONO-1101

Interventions

ONO-1101DRUG

placebo for 1 minute IV

P

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room

You may not qualify if:

  • Previous allergic reactions to contrast agent
  • Renal failure
  • Asthma
  • Concomitant beta-receptor blocking agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kinki Region

Kinki, Japan

Location

Related Publications (1)

  • 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.

    PMID: 23784548DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

landiolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Shinichi Kikawa

    Ono Pharmaceutial Co., Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

November 1, 2007

Primary Completion

November 1, 2008

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(1)