NCT00212680

Brief Summary

The purpose of this study was to evaluate the dose-dependent effects of ONO-1101 on efficacy and safety in patients with postoperative supraventricular tachyarrhythmias.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

9.3 years

First QC Date

September 13, 2005

Last Update Submit

October 10, 2012

Conditions

Postoperative Supraventricular Tachyarrythmia

Keywords

ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients achieving 20% reduction in heart rate at each dose

Secondary Outcomes (1)

  • Heart Rate, Blood pressure and 12-lead ECG

Interventions

ONO-1101DRUG

Eligibility Criteria

Age21 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Postoperative supraventricular tachyarrhythmias (sinus tachycardia, those with a heart rate of 120 beats/min or higher, and supraventricular arrhythmia, those with a heart rate of 100 beats/min or higher)
  • Within 7 days postoperatively

You may not qualify if:

  • Acute myocardial infarction (within 1 month after onset)
  • Severe heart failure (New York Heart Association functional class III or higher)
  • Atrioventricular block (grade II or higher),or sick sinus syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

landiolol

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 1996

Primary Completion

April 1, 2006

Last Updated

October 11, 2012

Record last verified: 2012-10