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

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ClinicalTrials.gov Identifier: NCT00568945
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Capadenoson (BAY68-4986) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2008
Primary Completion Date : November 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Capadenoson (BAY68-4986)
4 mg BAY68-4986 for five days



Primary Outcome Measures :
  1. The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. To investigate safety and tolerability of this treatment with capadenoson [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568945


Locations
Germany
Erfurt, Thüringen, Germany, 99084
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00568945     History of Changes
Other Study ID Numbers: 12679
2007-003619-30 ( EudraCT Number )
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014

Keywords provided by Bayer:
Atrial Fibrillation
Capadenoson

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes