NL-OMON41577已完成不适用
A Multi-center, Parallel-group, Double-blind, Placebo-controlled, Randomized, Ascending Dose Trial to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Infusions of OPC-108459 Administered to Subjects with Paroxysmal and Persistent Atrial Fibrillation. - OPC-108459 in Subjects with Paroxysmal & Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male and female subjects, ages of legal consent up to 85 years old, inclusive.
- •2. Patients with paroxysmal AF (recent or new onset) duration defined as 3 hours to <= 7 days (Group 1 only); or patients with persistent AF duration defined as >7 days and <= 12 months (Group 2 only) at the time of randomization. Duration of AF will be based on clinical assessments, review of subject medical records, and the judgment of the PI, and should be documented to establish the date of onset and duration of AF.
- •3. Patients must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic < 100 mmHg.
- •4. Low risk of thromboembolic potential as documented by
- •* Subjects with AF lasting < 48 hours (by ECG);
- •* Subjects with AF duration longer than 48 hours who have had: a) 3 weeks of anticoagulation therapy with warfarin and an International Normalized Ratio (INR) of 2.0-3.0 prior to dosing, or 3 weeks of another locally-approved anticoagulant therapy such as dabigatran or a factor Xa inhibitor, or b) a TEE to establish the absence of atrial main body or appendage thrombus within 24 hours prior to dosing. Adequate anticoagulation with warfarin (requires INR monitoring), dabigatran, or a factor Xa inhibitor needs to be in place at the time of drug infusion and continued after cardioversion as per local guidelines.
- •5. Subjects managed in accordance with American College of Cardiology/American Heart Association/European Society of Cardiology anticoagulation guidelines or in accordance with more recently-approved compounds as approved for this indication by the FDA. Prescreening treatment with beta-adrenergic blocking agents, calcium antagonists and digoxin for control of ventricular rate is permitted.
- •6. Male and female subjects who are surgically sterile (ie, have undergone orchidectomy or hysterectomy, respectively); female subjects who have been postmenopausal for at least 12 consecutive months; male and female subjects who agree to remain abstinent or to practice double-barrier forms of birth control from trial screening through 30 days from the last dose of IMP. Double barrier forms of birth control include use of two of the following precautions: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, or birth control depot injections combined with either condom, or sponge with spermicide.
排除标准
- •1. History of long QT syndrome, Torsade de Pointes or an uncorrected QT interval of > 450 msec.
- •2. QRS interval > 120 msec at Screening.
- •3. History of myocardial infarction within 6 months of Screening.
- •4. Symptoms of acute coronary syndrome, angina, or active myocardial ischemia diagnosed by ECG, or imaging stress testing within 6 months of Screening.
- •5. History of ventricular tachycardia, fibrillation, or resuscitated cardiac arrest.
- •6. History of clinically significant congenital heart disease.
- •7. Presence of severe aortic or mitral stenosis (valve area < 1.0 cm-sq), aortic or mitral regurgitation (greater than moderate severity), atrial septal defect, greater than mild pulmonary hypertension, or other conditions leading to AF with echo confirmation of this within the 12
- •months prior to Screening.
- •9. Part 1: Any subject with a diagnosis of heart failure NYHA Class II - IV or with an EF < 40%.
- •Part 2: Subjects with a diagnosis of heart failure NYHA Class IV or NYHA I, II or III with an EF < 35%, as determined by any imaging method within 6 months of Screening.
- •10. Subjects that have received concomitant treatment with class I or III antiarrhythmic agents unless the medication was discontinued more than 5 half-lives before dosing.
- •11. History of seizures.
- •12. Current diagnosis of atrial flutter.
- •13. Diagnosis of stroke, transient ischemic attack, or any transient neurological deficit within 1 year of Screening or known carotid artery stenosis of >50%.
- •14. Cardiac surgery within 3 months of Screening.
- •15. Bradycardia (< 50 bpm) or sick sinus syndrome, unless controlled by a pacemaker.
- •16. Current reversible cause of AF such as hyperthyroidism, pulmonary embolism, alcohol intoxication, pericarditis.
- •17. Wolff-Parkinson-White syndrome.
- •18. Subject diagnosed with any congenital abnormality, severe valve disease eg, aortic or mitral stenosis, severe right or left systolic dysfunction or severe pulmonary hypertension. This can be confirmed by TEE during Screening.
- •21. The following laboratory results at Screening: serum potassium < 3.5 mEq/L, magnesium < 1.5 mEq/L, serum creatinine >= 1.8 g/dL, hemoglobin < 9 g/dL in women or < 11 g/dL in men and liver enzymes 1.5 upper limit of normal.
- •22. Administration of another investigational product within 30 days of dosing.
- •24. Any medical condition, in the opinion of the investigator, which could
- •interfere with evaluation of the trial objectives or safety of the subjects (eg, antiarrhythmic agents, previous cardiac ablation or cardioversion).
- •25. Persons who are confined in an institution or jail
- •26. Women who are pregnant or breast-feeding
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