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

This study has been completed.

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212680

Purpose

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.

Condition	Intervention	Phase
Postoperative Supraventricular Tachyarrythmia	Drug: ONO-1101	Phase II

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

Drug Information available for: Ono 1101

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Heart Rate, Blood pressure and 12-lead ECG

Estimated Enrollment:	100
Study Start Date:	December 1996

Eligibility

Ages Eligible for Study:	21 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

20-80 years old
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)
Within 7 days postoperatively
Other inclusion criteria as specified in the protocol

Exclusion Criteria:

Acute myocardial infarction (within 1 month after onset)
Severe heart failure (New York Heart Association functional class III or higher)
Atrioventricular block (grade II or higher),or sick sinus syndrome
Other exclusion criteria as specified in the protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212680

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Project Leader, Development Planning

Ono Pharma

More Information

Study ID Numbers:	ONO-1101-1906
Study First Received:	September 13, 2005
Last Updated:	April 3, 2006
ClinicalTrials.gov Identifier:	NCT00212680
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Landiolol
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Neurotransmitter Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009