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NCT00568945 Clinical Trial

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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568945
Other study ID # 12679
Secondary ID 2007-003619-30
Status Completed
Phase Phase 2
First received October 25, 2007
Last updated October 28, 2014
Start date January 2008
Est. completion date December 2008

Study information
Verified date October 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Capadenoson (BAY68-4986)
4 mg BAY68-4986 for five days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation 1 week Yes
Secondary To investigate safety and tolerability of this treatment with capadenoson 2 weeks Yes
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