Atrial fibrillation MedDRA version: 9.1 Level: LLT Classification code 10016566 Term: Fibrillation atrial
Conditions
Interventions
Product Name: Bay 68-4986
Product Code: Bay 68-4986
Pharmaceutical Form: Granules for oral suspension
INN or Proposed INN: capadenoson
CAS Number: 544417-40-5
Current Sponsor code: Bay 68-4986
Concent
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Patients with a ventricular HR > 120 bpm under previous Afib treatment Patients with a ventricular HR 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Germany
Outcome results
None listed