Atrial FibrillationPhase 2NCT00568945
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.
A Phase 2 study testing Capadenoson (BAY68-4986) in people with Atrial Fibrillation, run by Bayer at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Capadenoson (BAY68-4986)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female (without childbearing potential) white patients
- History of persistent or permanent atrial fibrillation
- 18 to 75 years of age
Who cannot join
- Patients with high-risk cardiovascular diseases
- Stroke or myocardial infarction
- Relevant pathological changes in the ECG or echocardiography
- Medication affecting ventricular response in Afib
Trial locations and contacts
1 site in 1 country.
About this study
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
This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Capadenoson (BAY68-4986)
- Keywords
- Atrial Fibrillation, Capadenoson
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capadenoson (BAY68-4986)Drug
4 mg BAY68-4986 for five days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Capadenoson (BAY68-4986) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
Measured: 1 week
Secondary outcomes (1)
To investigate safety and tolerability of this treatment with capadenoson
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568945
- Sponsor's protocol ID
- 12679
- Other IDs
- 2007-003619-30
- Status last verified
- Oct 2014
- First submitted
- 25 Oct 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00568945
- Acronym / sponsor ID
- 12679
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Capadenoson
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Capadenoson (BAY68-4986) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female (without childbearing potential) white patients
- History of persistent or permanent atrial fibrillation
- 18 to 75 years of age
Key exclusion criteria (4 listed)
- Patients with high-risk cardiovascular diseases
- Stroke or myocardial infarction
- Relevant pathological changes in the ECG or echocardiography
- Medication affecting ventricular response in Afib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capadenoson (BAY68-4986)4 mg BAY68-4986 for five days | Drug | Arm 1 |
Primary outcome
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation
Time frame: 1 week
1 secondary outcome
To investigate safety and tolerability of this treatment with capadenoson
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capadenoson (BAY68-4986) in people with Atrial Fibrillation, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.