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

Ono Pharmaceutical Co. Ltd165 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

165

Conditions

Postoperative Supraventricular Tachyarrythmia

Interventions

ONO-1101DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Heart rate, blood pressure, rate-pressure-product and ECG

Data from ClinicalTrials.gov

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