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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:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00568945
First received: October 25, 2007
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568945

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00568945     History of Changes
Other Study ID Numbers: 12679, 2007-003619-30
Study First Received: October 25, 2007
Last Updated: June 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Atrial Fibrillation
Capadenoson

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

ClinicalTrials.gov processed this record on May 23, 2013