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 9, 2013
Last verified: June 2013
  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:


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:
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 9, 2013
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 April 15, 2014