Atrial FibrillationPhase 1NCT02069119
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)
A Phase 1 study testing OPC-108459 in people with Atrial Fibrillation, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- OPC-108459
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2014to Aug 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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 antithrombotic drug) which does not meet the above criterion
- Patients with systolic blood pressure (sBP) of 90 mmHg or higher and lower than 160 mmHg and diastolic blood pressure (dBP) of lower than 100 mmHg at screening examinations
- Female patients who have been postmenopausal for at least 12 consecutive months, or male and female patients who agree, together with their partners, to practice birth control as specified until 3 months after the start of IMP administration or who are surgically sterile (ie, have undergone orchiectomy or hysterectomy, respectively)
Who cannot join
- QRS interval of > 120 msec
- Patients with heart failure of New York Heart Association (NYHA) Class II to IV or with left ventricular ejection fraction (LVEF) of < 40%
- Patients who currently have or have a history of a long QT syndrome, torsade de pointes, or an uncorrected QT interval of > 450 msec
- History of ventricular tachycardia, ventricular fibrillation, or resuscitated cardiac arrest
- History of AF and failed electrical or pharmacological cardioversion
- Current diagnosis of atrial flutter
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- Patients with bradycardia (< 50 beats per minute [bpm]) or sick sinus syndrome, unless controlled by a pacemaker, except for physiologically transient sinus bradycardia observed at rest or during sleep
- Patients with Wolff-Parkinson-White syndrome
- Patients with any congenital severe heart disease
- Patients with severe aortic or mitral stenosis (aortic-valve area, < 1 cm2), severe mitral regurgitation, aortic regurgitation, congenital atrial septal defect, moderate or severe pulmonary hypertension, or any other disease leading to AF confirmed by echocardiography within one year prior to screening examinations
- Patients diagnosed with congenital valvular anomaly or severe valve disease (eg, aortic or mitral stenosis, severe right or left ventricular systolic dysfunction, or severe pulmonary hypertension) and confirmed current presence of the condition by TEE at screening examinations
- Patients diagnosed with stroke or transient ischemic attack within one year prior to screening examinations or with carotid artery stenosis of 50%
- History of myocardial infarction within 6 months prior to screening examinations
- Findings of acute coronary syndrome, angina, or myocardial ischemia diagnosed by ECG or drug-induced or exercise stress testing within 6 months prior to screening examinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Parallel-group-comparison, Double-blind, Placebo-controlled, Randomized 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
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
- Conditions
- Atrial Fibrillation
- Being tested
- OPC-108459, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPC-108459Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| OPC-108459 | Experimental | OPC-108459 solution will be intravenously administered by 30-minute infusion in the forearm. Receives: Drug: OPC-108459 |
| Placebo | Placebo comparator | placebo solution will be intravenously administered by 30-minute infusion in the forearm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF
24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg
The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
Measured: 90 minutes
Subjects Achieving NSR in Patients With Persistent AF
24 subjects with persistent AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg
The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
No subjects achieved NSR within 90 minutes after the start of IMP administration in the persistent AF cohort.
Measured: 90 minutes
Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, 19 subjects were included in the PK analysis, and one subject was excluded.
Measured: 0, 30, 50 minute and 2, 4, 8, 24 hour
Cmax of Plasma OPC-108459 in Patients With Persistent AF
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, all subjects were included in the PK analysis.
Measured: 0, 30, 50 minute and 2, 4, 8, 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069119
- Sponsor's protocol ID
- 269-13-001
- Status last verified
- Apr 2018
- First submitted
- 20 Feb 2014
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Parallel-group-comparison, Double-blind, Placebo-controlled, Randomized 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
- ClinicalTrials.gov ID
- NCT02069119
- Acronym / sponsor ID
- 269-13-001
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPC-108459 | Experimental | Drug: OPC-108459OPC-108459 solution will be intravenously administered by 30-minute infusion in the forearm. |
| Placebo | Placebo comparator | Drug: Placeboplacebo solution will be intravenously administered by 30-minute infusion in the forearm. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patients with systolic blood pressure (sBP) of 90 mmHg or higher and lower than 160 mmHg and diastolic blood pressure (dBP) of lower than 100 mmHg at screening examinations
Key exclusion criteria (14 listed)
- QRS interval of > 120 msec
- Patients with heart failure of New York Heart Association (NYHA) Class II to IV or with left ventricular ejection fraction (LVEF) of < 40%
- Patients who currently have or have a history of a long QT syndrome, torsade de pointes, or an uncorrected QT interval of > 450 msec
- History of ventricular tachycardia, ventricular fibrillation, or resuscitated cardiac arrest
- History of AF and failed electrical or pharmacological cardioversion
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 |
|---|---|---|
| OPC-108459 | Drug | OPC-108459 |
| Placebo | Drug | Placebo |
Primary outcome
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF
Time frame: 90 minutes
24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
Subjects Achieving NSR in Patients With Persistent AF
Time frame: 90 minutes
24 subjects with persistent AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute. No subjects achieved NSR within 90 minutes after the start of IMP administration in the persistent AF cohort.
Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF
Time frame: 0, 30, 50 minute and 2, 4, 8, 24 hour
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, 19 subjects were included in the PK analysis, and one subject was excluded.
Cmax of Plasma OPC-108459 in Patients With Persistent AF
Time frame: 0, 30, 50 minute and 2, 4, 8, 24 hour
Of 20 subjects for whom plasma OPC-108459 concentrations were measured, all subjects were included in the PK analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPC-108459 in people with Atrial Fibrillation, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
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 10 inclusion and 14 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 5 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF (time frame: 90 minutes). The study lists 4 primary outcomes in all. 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 5 Nov 2018.