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

Phase 2

Completed

• Conditions: Postoperative Supraventricular Tachyarrythmia

• Registration Number: NCT00212680
• Lead Sponsor: Ono Pharma USA Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Primary Completion: 2006-04
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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
4. Other inclusion criteria as specified in the protocol

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
4. Other exclusion criteria as specified in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving 20% reduction in heart rate at each dose

Secondary Outcome Measures

Name	Time	Method
Heart Rate, Blood pressure and 12-lead ECG