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

This study has been completed.

First Received on June 18, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation

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 February 09, 2012