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


Tracking Information

Start Date  ICMJEApril 2008
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2008)		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 ]
Original Primary Outcome Measures ICMJE 
 (submitted: May 19, 2008)		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).
Change HistoryComplete list of historical versions of study NCT00680186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 9, 2008)		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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: May 19, 2008)		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.

Descriptive Information

Brief Title  ICMJEPhase III Stydy Testing Efficacy & Saftety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp VTE
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEThromboembolism
Intervention  ICMJE
  • Drug: dabigatran etexilate (150 mg bid)
  • Drug: warfarin (INR 2.0-3.0)

Recruitment Information

Estimated Enrollment  ICMJE2554
Completion Date 
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Boehringer Ingelheim Study Coordinator1-800-243-0127clintriage.rdg@boehringer-ingelheim.com
Location Countries  ICMJEUnited States,   Australia,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   Denmark,   France,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   New Zealand,   Norway,   Philippines,   Poland,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00680186
Responsible PartyBoehringer Ingelheim, Study Chair, Boehringer Ingelheim
Study ID Numbers  ICMJE1160.46, EudraCT : 2007-002631-86
Study Sponsor  ICMJEBoehringer Ingelheim Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Chair:Boehringer IngelheimBoehringer Ingelheim Pharmaceuticals
Information Provided ByBoehringer Ingelheim Pharmaceuticals