EUCTR2011-001134-42-DE进行中（未招募）不适用
A phase 2, proof of concept, randomised, placebo-controlled, parallel group study to evaluate the effect of ranolazine and dronedarone when given alone and in combination on atrial fibrillation burden in subjects with paroxysmal atrial fibrillation - HARMONY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females aged 18 years and older
- •2. Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- •3. History of PAF documented within the prior 12 months
- •— Patients with PAF undergoing cardioversion greater than 4 weeks prior to Screening are eligible
- •4. Implanted (at least 3 months prior to Screening) dual chamber programmable pacemakers with AF detection capabilities
- •5. AFB = 1% and = 70% between the last clinic evaluation and Screening (minimum of 1 month observation period) and AFB = 2% and = 70% during the 4-week Run-in period
- •6. Sexually active females of childbearing potential must agree to utilize effective methods of contraception during heterosexual intercourse throughout the treatment period and for
- •14 days following discontinuation of the study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Persistent AF or Permanent AF
- •2. History of atrial flutter or atrial tachycardia without successful ablation
- •3. Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis, or pulmonary embolism
- •4. New York Heart Association Class III and IV heart failure or NYHA Class II heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to Screening.
- •5. Recent history of left ventricular ejection fraction < 40%
- •6. Myocardial infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to Screening or percutaneous coronary intervention within 4 weeks prior to Screening
- •7. Clinically significant valvular disease in the opinion of the Investigator
- •8. Stroke within 3 months prior to Screening
- •9. History of serious ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation) within 4 weeks prior to Screening
- •10. Family history of long QT syndrome
- •11. QTc > 470 msec (Bazett) at Screening ECG if in sinus rhythm (SR). If in AF, evidence of QTc > 470 msec (Bazett) within 4 weeks prior to Screening
- •12. Prior heart transplant
- •13. Cardiac ablation within 4 months prior to Screening, or planned ablation during the course of the study
- •14. Need for concomitant treatment during the trial, with drugs or products that are strong inhibitors of CYP3A, or inducers of CYP3A
- •— Such medications should be discontinued 5-half lives prior to the Run-in period
- •15. Use of grapefruit juice or Seville orange juice during the study
- •16. Use of Class I and Class III antiarrhythmic drugs other than amiodarone within 5-half lives prior to the Run-in period
- •17. Use of amiodarone within 3 months prior to Screening
- •18. Use of drugs that prolong the QT interval
- •19. Previous use of ranolazine or dronedarone within 2 months prior to screening
- •20. Prior use of ranolazine or dronedarone which was discontinued for safety or tolerability
- •21. Use of digitalis preparations (eg, digoxin) during the study
- •22. Use of a greater than 1000 mg total daily dose of metformin during the study
研究者
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