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

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040001
• Other study ID #: DTI-0009/003
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2002
• Last updated: June 23, 2005

Study information

• Verified date: February 2003
• Source: Aderis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• DTI-0009

Locations

Country	Name	City	State
United States	Multiple locations	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Aderis Pharmaceuticals

Country where clinical trial is conducted

United States,