Official Title: “A Phase III, Randomised, Double Blind, Parallel-Group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.”

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin PRN to maintain an INR of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a

parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE.

After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Dabigatran etexilate
• Drug: Warfarin

Primary Measures

• Composite of recurrent symptomatic venous thromboembolism (VTE) and deaths related to VTE within 6 months. VTE is defined as the composite incidence of deep vein thrombosis (DVT) of the leg and pulmonary embolism (PE).
  • Time Frame: 6 months
    

Secondary Measures

• Composite of recurrent symptomatic VTE and all deaths, symptomatic DVT, symptomatic PE, deaths related to VTE and all deaths. Bleeds, adverse events (AEs), discontinuation due to AEs, laboratory measures, Acute Coronary Syndromes, ECG and vital signs.
  • Time Frame: 6 months
    

Inclusion Criteria:

• 1. Acute symptomatic uni- or bilateral deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) confirmed by definitive objective clinical test in patients for whom at least 6 months of anticoagulant therapy is considered appropriate by the investigator
• 2. Male or female, being 18 years of age or older
• 3. Written informed consent for study participation

Exclusion Criteria:

• 1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
• 2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
• 3. Actual or anticipated use of vena cava filter
• 4. Contraindications to anticoagulant therapy including contraindications to heparins or other alternate approved therapy used for initial treatment, and warfarin
• 5. Patients who in the investigators opinion should not be treated with warfarin
• 6. Allergy to heparins (including history of heparin induced thrombocytopenia) or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
• 7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
• 8. Known anaemia
• 9. Need of anticoagulant treatment for disorders other than VTE
• 10. Recent unstable cardiovascular disease
• 11. Elevated AST or ALT > 2x ULN based on the local lab results obtained at screening and prior to randomisation (or central screening lab if available on time)
• 12. Liver disease expected to have any potential impact on survival (e.g. acute hepatitis, possibly active hepatitis B, hepatitis C or cirrhosis, but not Gilberts syndrome or hepatitis A with complete recovery)
• 13. Patients who have developed transaminase elevations upon exposure to ximelagatran
• 14. Severe renal impairment (estimated creatinine clearance 30 ml/min)
• 15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
• 16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
• 17. Patients considered unsuitable for inclusion by the investigator

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00291330

Study ID Number: 1160.53

ClinicalTrials.gov Identifier: NCT00291330

Health Authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology)