A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a S… (NCT02069119) | Clinical Trial Compass
CompletedPhase 1
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
Japan48 participantsStarted 2014-02
Plain-language summary
To investigate the safety, pharmacokinetics, and efficacy following 30-minute continuous intravenous administration of OPC-108459 at 0.4, 0.8, 1.6, or 2.4 mg/kg or placebo to patients with paroxysmal or persistent atrial fibrillation
Who can participate
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Japanese
* Male or female age 20 to 85 years, inclusive (at the time of informed consent)
* Patients diagnosed with recent or new onset of paroxysmal AF (3 hours to 7 days since the onset) or persistent AF (8 to 30 days since the onset) at time of randomization (prior to Investigational Medicinal Product \[IMP\] administration). Review of the patient's medical records and the judgment of the investigator or sub-investigator must be documented in the source documents to establish the date and duration of the most recent onset of AF.
* Patients who are receiving treatment according to the "Guidelines for Pharmacotherapy of Atrial Fibrillation (JCS 2008)" at time of screening and predosing examinations or who have a low risk of thromboembolic potential specified as follows:
* AF lasting less than 48 hours, OR
* For AF lasting for 48 hours or longer:
* Patients receiving warfarin therapy for whom at least 3 weeks have elapsed since achieving an international normalized ratio (INR) of 2.0 to 3.0 (1.6 to 2.6 for patients age 70 years or older) or in whom no thrombus in the atrial main body or appendage is observed by transesophageal echocardiography (TEE) within 24 hours before IMP administration
* Patients in whom no thrombus in the atrial main body or appendage is observed by TEE within 24 hours before IMP administration if they have not undergone antithrombotic therapy or if they have undergone antithrombotic therapy (including a new oral ant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF
Timeframe: 90 minutes
2
Subjects Achieving NSR in Patients With Persistent AF
Timeframe: 90 minutes
3
Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF
Timeframe: 0, 30, 50 minute and 2, 4, 8, 24 hour
4
Cmax of Plasma OPC-108459 in Patients With Persistent AF