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Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
Aderis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040001
First received: June 18, 2002
Last updated: June 23, 2005
Last verified: February 2003
History of Changes
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
 Drug: DTI-0009
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aderis Pharmaceuticals:

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040001

Locations
United States, Virginia
Multiple locations
Richmond, Virginia, United States
Sponsors and Collaborators
Aderis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040001     History of Changes
Other Study ID Numbers: DTI-0009/003
Study First Received: June 18, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Purinergic P1 Receptor Agonists
 Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013