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

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ClinicalTrials.gov Identifier: NCT00212654
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd

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

Condition or disease Intervention/treatment Phase
Postoperative Supraventricular Tachyarrythmia Drug: ONO-1101 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
Study Start Date : June 2001
Actual Primary Completion Date : April 2006



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Heart rate, blood pressure, rate-pressure-product and ECG


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00212654


Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd

Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212654     History of Changes
Other Study ID Numbers: ONO-1101-21
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
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