- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00212654
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
October 10, 2012 updated by: Ono Pharmaceutical Co. Ltd
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
165
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 84 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20 years or older
- Postoperative supraventricular tachyarrhythmias
- 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 (NYHA) functional class III or higher]
- Atrioventricular block (grade II or higher), or sick sinus syndrome
- Other exclusion criteria as specified in the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Heart rate, blood pressure, rate-pressure-product and ECG
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Primary Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
October 11, 2012
Last Update Submitted That Met QC Criteria
October 10, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Tachycardia
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Landiolol
Other Study ID Numbers
- ONO-1101-21
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Supraventricular Tachyarrythmia
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Ono Pharma USA IncCompletedPostoperative Supraventricular Tachyarrythmia
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Milestone Pharmaceuticals Inc.Medpace, Inc.CompletedParoxysmal Supraventricular Tachycardia (PSVT)United States, Canada
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Milestone Pharmaceuticals Inc.TerminatedParoxysmal Supraventricular Tachycardia (PSVT)United States
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Medtronic Bakken Research CenterMedtronicCompleted
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