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

This study has been completed.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ) Identifier:
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan

Further study details as provided by Ono Pharmaceutical Co. Ltd:

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
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00212680

Sponsors and Collaborators
Ono Pharma USA Inc
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd
  More Information

Responsible Party: Ono Pharma USA Inc Identifier: NCT00212680     History of Changes
Other Study ID Numbers: ONO-1101-1906
Study First Received: September 13, 2005
Last Updated: October 10, 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents processed this record on April 28, 2017