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

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Postoperative Supraventricular Tachyarrythmia

Treatments: Drug: ONO-1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212680

ONO-1101-1906

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)