Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp VTE

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.

Intervention(s) in this Clinical Trial

• Drug: Dabigatran etexilate
  • 150mg bid
• Drug: Warfarin
  • PRN (to maintain a target INR of 2.0-3.0)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Dabigatran etexilate (150mg bid)
  • Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
• Active Comparator: Warfarin (INR 2.0-3.0)
  • Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 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
    Safety Issue?: No

Secondary Measures

• Symptomatic PE
  • Time Frame: 6 months
    Safety Issue?: No
• Discontinuation due to AE
  • Time Frame: 6 months
    Safety Issue?: Yes
• Laboratory measures
  • Time Frame: 6 months
    Safety Issue?: Yes
• Deaths related to VTE
  • Time Frame: 6 months
    Safety Issue?: No
• All deaths
  • Time Frame: 6 months
    Safety Issue?: No
• Incidence of Bleeding Events
  • Time Frame: 6 months
    Safety Issue?: Yes
• AE
  • Time Frame: 6 months
    Safety Issue?: Yes
• ACS
  • Time Frame: 6 months
    Safety Issue?: Yes
• Vital signs
  • Time Frame: 6 months
    Safety Issue?: Yes
• Composite of recurrent symptomatic VTE and all deaths
  • Time Frame: 6 months
    Safety Issue?: No
• Symptomatic DVT
  • Time Frame: 6 months
    Safety Issue?: No

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 Investigator: Boehringer Ingelheim Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: 1160.46

ClinicalTrials.gov Identifier: NCT00680186

Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin