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

Phase 2

Completed

• Conditions: Postoperative Supraventricular Tachyarrythmia

• Registration Number: NCT00212654
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• 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: 165

Inclusion Criteria

1. 20 years or older
2. Postoperative supraventricular tachyarrhythmias
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 (NYHA) 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: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Heart rate, blood pressure, rate-pressure-product and ECG