Back to resultsSafety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DTI-0009
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria Primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ECG Exclusion Criteria Presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study
Sites / Locations
- Multiple locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040001
Brief Title
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Aderis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study is designed to evaluate the safety of DTI-0009 in patients with atrial fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial fibrillation with rapid ventricular response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
DTI-0009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Primary diagnosis of atrial fibrillation with rapid ventricular response of any duration as documented by an ECG
Exclusion Criteria
Presence of other significant cardiac disease or history of significant neurological, hepatic,cardiovascular, renal, gastrointestinal, thyroid, respiratory, rheumatologic, or hematologic disease or impairment that in the investigator's judgment is serious enough to preclude the patient from safely participating in the study
Facility Information:
Facility Name
Multiple locations
City
Richmond
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
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