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

Ono Pharma USA Inc100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Postoperative Supraventricular Tachyarrythmia

Interventions

ONO-1101DRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Heart Rate, Blood pressure and 12-lead ECG

Data from ClinicalTrials.gov

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