A comparative bioequivalence study of warfarin brands in cardiovascular patients

Phase 4

• Conditions: Atrial fibrillation; Venous thrombosis; Pulmonary embolism; Recurrent emboli; Prosthetic valve replacement; Acute myocardial infarction (to prevent systemic embolism); Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12613000702718
• Lead Sponsor: Therapeutcs Research Centre, University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age greater than or equal to 18 years
2. Receiving warfarin treatment
3. Clinically stable with the same dose of warfarin yielding a stable (less than 0.5 unit change over the lead-in period) of INR value that falls within the target therapeutic range (2.0 -3.0 or 2.5-3.5) for at least 6 weeks

Exclusion Criteria

1. Age less than 18 years
2. Allergy to any ingredients in warfarin product
3. Pregnancy or breast feeding
4. Non-adherence tendency
5. Psychiatric disorder or dementia
6. Significant renal dysfunction (adjusted creatinine clearance calculated by Cockcroft-Gault equation < 60 mL/min)
7. Significant liver dysfunction (AST, ALT > 3 times of upper limits)
8. Excessive alcohol consumption
9. Taking any medications, food or dietary supplement that significantly interact with warfarin
10. Limited English communication proficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified