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OpenTrials
Completed

NCT Number: NCT00212680

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

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.

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Key information

Conditions

Postoperative Supraventricular Tachyarrythmia

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-80 years old
  • 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)
  • 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 functional class III or higher)
  • Atrioventricular block (grade II or higher),or sick sinus syndrome
  • Other exclusion criteria as specified in the protocol

Treatment and study plan

ONO-1101

Drug

Primary outcomes

  1. Percentage of patients achieving 20% reduction in heart rate at each dose

Secondary outcomes

  1. Heart Rate, Blood pressure and 12-lead ECG

Sponsors and collaborators

Lead sponsor

Ono Pharma USA Inc

Industry

Registry information

Important dates

Study start
1996
Primary completion
2006
First posted
Sep 21, 2005
Registry last updated
Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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