EUCTR2007-003619-30-DE进行中（未招募）不适用
Study to investigate the effect of the A1 agonist capadenoson on ventricular HR in patients with persistent or permanent atrial fibrillation by administration of capadenoson in a dose of 4 mg once daily for five days
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male and/or female (without childbearing potential) white patients
- •Female patients of non-childbearing potential:
- •History of persistent or permanent atrial fibrillation, that had been present for at least 6 months
- •18 to 75 years of age
- •BMI between 18 and 39.9 kg/m2
- •Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period
- •Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with a ventricular HR > 120 bpm under previous Afib treatment
- •Patients with a ventricular HR < 80 bpm or > 140 bpm, without previous treatment
- •Patients with high-risk cardiovascular diseases (e.g., uncontrolled heart failure, congestive heart failure (NYHA Class III – IV), WPW syndrome, sick sinus syndrome, implanted pacemaker, or defibrillator, unstable angina, severe aortic stenosis, severe hypertrophic obstructive cardiomyopathy, dissecting aneurysm, severe valvular heart disease)
- •History of torsades de pointes
- •Polymorphic ventricular tachycardia
- •Patients with acute systemic infection
- •Acute myocarditis or pericarditis
- •Patients with recent aortic surgery
- •Stroke, or myocardial infarction within the previous 3 months
- •Uncontrolled hypertension (systolic blood pressure >160 mm Hg, diastolic >100 mm Hg)
- •Persistent systolic blood pressure < 95 mm Hg
- •Echocardiographic LVEF < 35%
- •Donation of more than 250 mL of blood in the preceding 4 weeks
- •Blood donation of approximately 500 mL in the preceding 3 months
- •Febrile illness within 1 week before the start of the study
- •Regular daily consumption of more than one liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form;
- •Regular daily consumption of more than 1 liter of xanthin-containing beverages;
- •Regular daily consumption of more than 25 cigarettes;
- •Clinically relevant deviation from the normal range in clinical chemistry, hematology or urinalysis
- •Liver function tests (AST, ALT, LDH) >3 times the upper limit of normal at screening
- •Serum creatinine >2.0 mg/dl or >200 micromol/L at screening
- •Patients testing positive in the drug screening
- •Pregnancy or lactation in women of child-bearing potential and/or reproductive status
- •Excluded therapies: drug concomitant with study drug that might affect HR
- •Relevant pathological changes in the ECG such as a second or third-degree AV block, or of the QTc-interval over 450 msec for males and over 470 msec for females
- •Medication affecting ventricular response in Afib e.g. theophyllin, clonidine, beta-agonists
- •Concurrent use of CYP 2C9 substrates such as fluvastatin, diclofenac, losartan, rosiglitazone, glibenclamide/glyburide, tolbutamide
- •Clinically relevant renal, hepatic or thyroid dysfunction
- •Significant mental illness
- •Participation in another clinical trial during the preceding 3 months
- •Patients with a medical disorder, condition or history of such that would impair the patient’s ability to participate or complete this study in the opinion of the investigator or the sponsor
- •Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
- •Patients with hypersensitivity to the investigational drug, the control agent and/ or to inactive constituents
- •Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
- •Patient is tested to be HIV-1/2Ab, HbsAg or HCV-Ab positive
- •Contraindications for metoprolol treatment, such as severe asthma bronchiale, chronic obstructive pulmonary disease (COPD), peripheral arterial occlusive disease (PAOD)
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