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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00212680
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 achieving 20% reduction in heart rate at each dose

Secondary Outcome Measures:
  • Heart Rate, Blood pressure and 12-lead ECG

Estimated Enrollment: 100
Study Start Date: December 1996
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212680

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

No publications provided

Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00212680     History of Changes
Other Study ID Numbers: ONO-1101-1906
Study First Received: September 13, 2005
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014