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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568945
First Posted: December 6, 2007
Last Update Posted: October 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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 Intervention Phase
Atrial Fibrillation Drug: Capadenoson (BAY68-4986) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Enrollment: 28
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Capadenoson (BAY68-4986)
4 mg BAY68-4986 for five days

  Eligibility

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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00568945     History of Changes
Other Study ID Numbers: 12679
2007-003619-30 ( EudraCT Number )
First Submitted: October 25, 2007
First Posted: December 6, 2007
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