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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212680
Enrollment
100
Registered
2005-09-21
Start date
1996-12-31
Completion date
Unknown
Last updated
2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Supraventricular Tachyarrythmia

Keywords

ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia

Brief summary

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.

Interventions

Sponsors

Ono Pharma USA Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of patients achieving 20% reduction in heart rate at each dose

Secondary

MeasureTime frame
Heart Rate, Blood pressure and 12-lead ECG

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026