EUCTR2011-001134-42-GB进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 134
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
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 = 3% and = 50% 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. History of persistent or permanent atrial fibrillation, or history of atrial flutter or atrial tachycardia without successful ablation
- •2. Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis, or pulmonary embolism
- •3. New York Heart Association (NYHA) 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.
- •4. 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
- •5. Clinically significant valvular disease in the opinion of the Investigator
- •6. Stroke within 3 months prior to Screening
- •7. History of serious ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation) within 4 weeks prior to Screening
- •8. QTc = 500 msec (Bazett) at Screening ECG if in sinus rhythm (SR). If in atrial fibrillation, evidence of QTc = 500 msec (Bazett) within 4 weeks prior to Screening
- •9. Prior heart transplant
- •10 Electrical cardioversion within 4 weeks prior to Screening
- •11. 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 study entry)
- •12. Use of grapefruit juice during the study
- •13. Use of Class I and Class III antiarrhythmic drugs other than amiodarone within 5-half lives prior to the Run-in period
- •14. Use of amiodarone within 3 months prior to Screening
- •15. Use of drugs that prolong the QT interval
- •16. No previous use of ranolazine or dronedarone within 6 months prior to screening
- •17. Prior use of ranolazine or dronedarone which was discontinued for safety or tolerability
- •18. Use of dabigatran during the study
- •19. Uncorrected hypokalemia (serum potassium < 3.5 mEq/L) at Screening
- •20. Moderate and severe hepatic impairment (i.e., Child-Pugh Class B and C), abnormal liver function test defined as ALT, AST, or bilirubin > 2 X ULN at Screening
- •21. Severe renal impairment defined as creatinine clearance = 30 mL/min at Screening
- •22. Females who are pregnant or are breastfeeding
研究者
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