Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00568945
First received: October 25, 2007
Last updated: October 28, 2014
Last verified: October 2014

October 25, 2007
October 28, 2014
January 2008
November 2008   (final data collection date for primary outcome measure)
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 5 days ]
Complete list of historical versions of study NCT00568945 on ClinicalTrials.gov Archive Site
To investigate safety and tolerability of this treatment with capadenoson [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Secondary objective of the study is to investigate safety and tolerability of this treatment with capadenoson. [ Time Frame: 8 days ]
Not Provided
Not Provided
 
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
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

This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Drug: Capadenoson (BAY68-4986)
4 mg BAY68-4986 for five days
Experimental: Arm 1
Intervention: Drug: Capadenoson (BAY68-4986)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and/or female (without childbearing potential) white patients
  • History of persistent or permanent atrial fibrillation
  • 18 to 75 years of age

Exclusion Criteria:

  • Patients with high-risk cardiovascular diseases
  • Stroke or myocardial infarction
  • Relevant pathological changes in the ECG or echocardiography
  • Medication affecting ventricular response in Afib
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00568945
12679, 2007-003619-30
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP