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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 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00212654
Enrollment
165
Registered
2005-09-21
Start date
2001-06-30
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 is to evaluate the efficacy and safety of ONO-1101 in postoperative supraventricular tachyarrhythmias.

Interventions

Sponsors

Ono Pharmaceutical Co. Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
21 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

1. 20 years or older 2. Postoperative supraventricular tachyarrhythmias 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 \[New York Heart Association (NYHA) functional class III or higher\] 3. Atrioventricular block (grade II or higher), or sick sinus syndrome 4. Other

Design outcomes

Primary

MeasureTime frame
Percentage of patients who met the heart rate reduction criteria (20% reduction from the baseline heart rate and a heart rate of <100 beats/min)

Secondary

MeasureTime frame
Heart rate, blood pressure, rate-pressure-product and ECG

Outcome results

None listed

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