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

Ono Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Supraventricular Tachyarrythmia

Treatments: Drug: ONO-1101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212654

ONO-1101-21

Details and patient eligibility

About

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

Sex: All

Ages: 21 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind