NCT00568945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
26 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

10 months

First QC Date

October 25, 2007

Last Update Submit

October 28, 2014

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCapadenoson

Outcome Measures

Primary Outcomes (1)

  • The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation

    1 week

Secondary Outcomes (1)

  • To investigate safety and tolerability of this treatment with capadenoson

    2 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Capadenoson (BAY68-4986)

Interventions

Capadenoson (BAY68-4986)DRUG

4 mg BAY68-4986 for five days

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and/or female (without childbearing potential) white patients
  • History of persistent or permanent atrial fibrillation
  • to 75 years of age

You may not qualify if:

  • Patients with high-risk cardiovascular diseases
  • Stroke or myocardial infarction
  • Relevant pathological changes in the ECG or echocardiography
  • Medication affecting ventricular response in Afib

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Erfurt, Thuringia, 99084, Germany

Location

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

capadenoson

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2007

First Posted

December 6, 2007

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

DE(1)