Postoperative Supraventricular TachyarrythmiaPhase 2NCT00212680
Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
A Phase 2 study testing ONO-1101 in people with Postoperative Supraventricular Tachyarrythmia, run by Ono Pharma USA Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Postoperative Supraventricular Tachyarrythmia
- What is being tested?
- ONO-1101
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 1996to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- ONO-1101
- Keywords
- ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-1101Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving 20% reduction in heart rate at each dose
Secondary outcomes (1)
Heart Rate, Blood pressure and 12-lead ECG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 1996
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Supraventricular TachyarrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212680
- Sponsor's protocol ID
- ONO-1101-1906
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of ONO-1101 in Patients With Postoperative Tachyarrhythmias in Japan
- ClinicalTrials.gov ID
- NCT00212680
- Acronym / sponsor ID
- ONO-1101-1906
- Keywords
- ONO-1101,Landiolol Hydrochloride, Postoperative, Supraventricular Tachyarrhythmia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Dec 1996
- Primary completion
- Apr 2006 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-1101 | Drug | – |
Primary outcome
Percentage of patients achieving 20% reduction in heart rate at each dose
1 secondary outcome
Heart Rate, Blood pressure and 12-lead ECG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader, Development Planning study director
Ono Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-1101 in people with Postoperative Supraventricular Tachyarrythmia, run by Ono Pharma USA Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving 20% reduction in heart rate at each dose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2012.