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
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10016566Term: Fibrillation atrialAtrial fibrillation
- Registration Number
- EUCTR2007-003619-30-DE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objective of the study is to investigate the effect of capadenoson (BAY 68-4986) 4 mg granulate once daily for 5 days on rate control in patients with atrial fibrillation in comparison to baseline. The reduction of HR will be assessed in a 24 h long term ECG as well as during an exercise tolerance test (ETT).;Primary end point(s): not applicable;Secondary Objective: Secondary objective of the study is to investigate safety and tolerability of this treatment with capadenoson.<br>In addition, the pharmacokinetic (PK) profile of capadenoson during this treatment will be assessed. The relationship between plasma concentrations of capadenoson and its effect on HR will also be investigated in patients with persistent or permanent atrial fibrillation.<br>
- Secondary Outcome Measures
Name Time Method