NCT00924586

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Geographic Reach
1 country

2 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

June 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

8 months

First QC Date

June 18, 2009

Last Update Submit

June 12, 2012

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Image quality

    one day

Secondary Outcomes (1)

  • Heart rate

    5 days maximum

Study Arms (2)

P

PLACEBO COMPARATOR
Drug: ONO-1101

E

EXPERIMENTAL
Drug: ONO-1101

Interventions

ONO-1101DRUG

Placebo for one minute IV

P

Eligibility Criteria

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

You may qualify if:

  • ≥ 20 years old
  • Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates.

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 (2)

Kanto Region

Kanto, Japan

Location

Kyushu Region

Kyushu, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

landiolol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mitsunobu Tanimoto

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2010

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

JP(2)