NCT00311038

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

3 active sites

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

April 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

First QC Date

April 3, 2006

Last Update Submit

June 12, 2012

Conditions

Keywords

ONO-1101Landiolol HydrochlorideMulti-slice CTCoronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • heart rate

  • image quality

  • safety

Interventions

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

You may not qualify if:

  • Previous allergic reactions to contrast agent
  • Renal failure
  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hokuriku Region Facility

Hokuriku, Japan

Location

Kanto Region Facility

Kanto, Japan

Location

Kyusyu Region Facility

Kyusyu, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

landiolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Project Leaders Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

April 1, 2006

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations