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A Controlled, Randomised, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837 in the Prevention of Stroke and other Thromboembolic Complications Associated with Atrial Fibrillation. - N/A

A Controlled, Randomised, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837 in the Prevention of Stroke and other Thromboembolic Complications Associated with Atrial Fibrillation. - N/A

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000359-41-SE
Enrollment
270
Registered
2004-07-01
Start date
2004-08-31
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of stroke and other thromboembolic complications associated with Atrial Fibrillation MedDRA version: 7.0 Level: PT Classification code 10003658

Interventions

Product Code: AZD0837 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet applied for CAS Number: N/A Current Sponsor code: AR-H067639XX Concentration unit: mg milligram(s) Concentration type: eq

Sponsors

AstraZeneca AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Paroxysmal, persisitent or permanent non valvular Atrial Fibrillation, verified by at least two ECGs in the last year separated by at least one week. At least one risk factor for stroke, in addition to Atrial Fibrillation. Age 65 years or more, and diabetes mellitus Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age less than 18 years Weight less than 50 kg, or more than 120 kg Female of child-bearing potential Atrial Fibrillation secondary to reversible disorders Presence of valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than Atrial Fibrillation requiring chronic anticoagulation treatment MI, CABG or PCI within the previous 3 months from visit 1 Stroke or TIA and/or systemic embolism within the previous 6 months from visit 1 Conditions associated with increased risk of bleeding

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate safety and tolerability of two different doses of AZD0837 in relation to warfarin during 3 months of treatment in Atrial Fibrillation patients with moderately increased risk of stroke.;Secondary Objective: To evaluate the pharmacokinetics of the active form of AZD0837 (AR-H067637XX) with special regard to variablility in the patient population. To evaluate the pharmacodynamics of AZD0837 in the patient population.;Primary end point(s): N/A—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026