Long-term safety in Atrial Fibrillation patients

Study identifier:D1250C00042

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Long-term treatment with the oral direct thrombin inhibitor AZD0837, compared to Vitamin-K antagonists, as stroke prevention in patients with non-valvular atrial fibrillation and one or more risk factors for stroke and systemic embolic events. A 5-year follow-up study

Medical condition

Persistent or Permanent Nonvalvular Atrial Fibrillation

Phase

Phase 2

Healthy volunteers

Study drug

AZD0837, VKA INR 2-3

Sex

All

Actual Enrollment

523

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Oct 2007

Primary Completion Date: 01 May 2009

Study Completion Date: 01 May 2009

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Verification:

Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: AZD0837 Treatment with AZD0837 starting with 4 different doses, 150 mg od, 300 mg od, 200 mg bid or 450 mg od and then switching to one general common dose, 300 mg od
Active Comparator: 2	Drug: VKA INR 2-3 Vitamin K antagonists (VKA), titrated to an international normalised ratio (INR) of 2.0 to 3.0 with a target value of 2.5 Other Name: warfarin

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=254&filename=CSR-D1250C00042.pdf
Download
CSR-D1250C00042.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Lars Hvilstedt Rasmussen

Head of Cardiology at Heart Centre Aalborg Aarhus University Hospital DK 9100 Aalborg Denmark