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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Supraventricular Tachyarrythmia

Keywords

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ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ONO-1101

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 20-80 years old
2. 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)
3. Within 7 days postoperatively

Exclusion Criteria

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader, Development Planning

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Other Identifiers

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ONO-1101-1906

Identifier Type: -

Identifier Source: org_study_id