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

This study has been completed.

Sponsored by:	Aderis Pharmaceuticals
Information provided by:	Aderis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00040001

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 II

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

Drug Information available for: Adenosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

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

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

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Atrial Fibrillation
Adenosine
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009