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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00568945
First received: October 25, 2007
Last updated: June 15, 2012
Last verified: June 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 25, 2007 | ||||
| Last Updated Date | June 15, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation [ Time Frame: 1 week ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
The effect of capadenoson (BAY 68-4986) 4 mg granulate once daily for 5 days on rate control in patients with atrial fibrillation in comparison to baseline. [ Time Frame: 5 days ] | ||||
| Change History | Complete list of historical versions of study NCT00568945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To investigate safety and tolerability of this treatment with capadenoson [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Secondary objective of the study is to investigate safety and tolerability of this treatment with capadenoson. [ Time Frame: 8 days ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation. | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Atrial Fibrillation | ||||
| Intervention ICMJE | Drug: Capadenoson (BAY68-4986)
4 mg BAY68-4986 for five days |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Drug: Capadenoson (BAY68-4986) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00568945 | ||||
| Other Study ID Numbers ICMJE | 12679, 2007-003619-30 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Therapeutic Area Head, Bayer HealthCare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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