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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 Identifier:
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.

Condition Intervention Phase
Postoperative Supraventricular Tachyarrythmia
Drug: ONO-1101
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 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:
  • Heart rate, blood pressure, rate-pressure-product and ECG

Estimated Enrollment: 165
Study Start Date: June 2001
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00212654

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

Responsible Party: Ono Pharmaceutical Co. Ltd Identifier: NCT00212654     History of Changes
Other Study ID Numbers: ONO-1101-21
Study First Received: September 13, 2005
Last Updated: October 10, 2012

Keywords provided by Ono Pharmaceutical Co. Ltd:
Landiolol Hydrochloride
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 27, 2017