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Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Primary Purpose

Postoperative Supraventricular Tachyarrythmia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ONO-1101

About this trial

This is an interventional treatment trial for Postoperative Supraventricular Tachyarrythmia focused on measuring ONO-1101, Landiolol Hydrochloride, Postoperative, supraventricular tachyarrhythmia

Eligibility Criteria

21 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 20 years or older Postoperative supraventricular tachyarrhythmias Within 7 days postoperatively Other inclusion criteria as specified in the protocol Exclusion Criteria: Acute myocardial infarction (within 1 month after onset) Severe heart failure [New York Heart Association (NYHA) functional class III or higher] Atrioventricular block (grade II or higher), or sick sinus syndrome Other exclusion criteria as specified in the protocol

Sites / Locations

Outcomes

Primary Outcome Measures

Percentage of patients who met the heart rate reduction criteria (20% reduction from the baseline heart rate and a heart rate of <100 beats/min)

Secondary Outcome Measures

Heart rate, blood pressure, rate-pressure-product and ECG

Full Information

NCT ID

NCT00212654

First Posted

September 13, 2005

Last Updated

October 10, 2012

Sponsor

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00212654

Brief Title

Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Official Title

Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

June 2001 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Supraventricular Tachyarrythmia

Keywords

ONO-1101, Landiolol Hydrochloride, Postoperative, supraventricular tachyarrhythmia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

165 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ONO-1101

Primary Outcome Measure Information:

Title

Percentage of patients who met the heart rate reduction criteria (20% reduction from the baseline heart rate and a heart rate of <100 beats/min)

Secondary Outcome Measure Information:

Title

Heart rate, blood pressure, rate-pressure-product and ECG

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Project Leader, Development Planning

Organizational Affiliation

Ono Pharmaceutical Co. Ltd

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

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