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 general aim of this study 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 VTE. The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Study Type: Interventional

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

Study Primary Completion Date: July 2011

Intervention(s) in this Clinical Trial

• Drug: dabigatran etexilate (150 mg bid)
• Drug: warfarin (INR 2.0-3.0)

Primary Measures

• A composite of recurrent symptomatic VTE and deaths related to VTE within 6 months (VTE is defined as the composite incidence of DVT of the leg (including the inferior caval vein) and PE).
  • Time Frame: 6 months
    

Secondary Measures

• Efficacy: Composite of recurrent symptomatic VTE and all deaths, Symptomatic DVT, Symptomatic PE, Deaths related to VTE, All deaths Safety: Incidence of Bleeding Events, AE, Discontinuation due to AE, Laboratory measures, ACS, vital signs.
  • Time Frame: 6 months
    

Inclusion Criteria:

• Acute symptomatic uni- or bilateral DVT of the leg involving proximal veins, and/or

PE

• Male or female, being 18 years of age or older
• Written informed consent for study participation

Exclusion Criteria:

• Persistent symptoms of VTE
• PE requiring urgent intervention
• Use of vena cava filter
• Contraindications to anticoagulant therapy
• Allergy to study medications
• Elevated AST or ALT > 3x ULN or known liver disease expected to have an impact on survival
• Severe renal impairment
• Patients considered unsuitable for inclusion

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  

Overall Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00680186

Study ID Number: 1160.46

ClinicalTrials.gov Identifier: NCT00680186

Health Authority: Australia: Responsilble Ethics Committee