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/PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Brief Summary

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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ONO-1101

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 20 years or older
2. Postoperative supraventricular tachyarrhythmias
3. Within 7 days postoperatively

Exclusion Criteria

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

84 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-1101-21

Identifier Type: -

Identifier Source: org_study_id