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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00212680 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
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Scientific title:
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Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan |
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Date of first enrolment:
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December 1996 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00212680 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Project Leader, Development Planning |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ono Pharmaceutical Co. Ltd |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Supraventricular Tachyarrythmia
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Intervention(s)
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Drug: ONO-1101
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Primary Outcome(s)
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Percentage of patients achieving 20% reduction in heart rate at each dose
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Secondary Outcome(s)
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Heart Rate, Blood pressure and 12-lead ECG
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Secondary ID(s)
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ONO-1101-1906
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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