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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212680
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ( Ono Pharma USA Inc ):

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)
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212680


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

Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00212680     History of Changes
Other Study ID Numbers: ONO-1101-1906
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Landiolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents