Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00680186
First received: May 16, 2008
Last updated: September 12, 2012
Last verified: September 2012
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Purpose
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thromboembolism |
Drug: Warfarin Drug: Dabigatran etexilate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Warfarin
Warfarin sodium
Dabigatran
Dabigatran etexilate
Dabigatran etexilate mesylate
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE [ Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) ] [ Designated as safety issue: No ]All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Secondary Outcome Measures:
- Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] [ Designated as safety issue: No ]VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Recurrent Symptomatic DVT [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] [ Designated as safety issue: No ]Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Recurrent Symptomatic Non-fatal PE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] [ Designated as safety issue: No ]Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants Who Died Due to VTE [ Time Frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) ] [ Designated as safety issue: No ]VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants Who Died (Any Cause) [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ] [ Designated as safety issue: No ]Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Number of Participants With Major Bleeding Events (MBE) [ Time Frame: From first intake of study drug to last intake of study drug + 6 days ] [ Designated as safety issue: Yes ]
MBEs defined as per the recommendations of the International Society on Thrombosis and Haemostasis. A bleeding event was categorised as an MBE (adjudicated by the independent central assessment committee) if it fulfilled at least one of the following criteria:
ââ " Fatal bleeding, ââ " Symptomatic bleeding in a critical area or organ, ââ " Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.
Other Outcome Measures:
- Number of Participants With Acute Coronary Syndrome (ACS) [ Time Frame: From first intake of study drug to last contact date ] [ Designated as safety issue: Yes ]Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
| Enrollment: | 2589 |
| Study Start Date: | April 2008 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
|
Drug: Dabigatran etexilate
150mg bid
|
|
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
|
Drug: Warfarin
PRN (to maintain a target INR of 2.0-3.0)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (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 Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
- Severe renal impairment
- Patients considered unsuitable for inclusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680186
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| United States, Arkansas | |
| 1160.46.01073 Boehringer Ingelheim Investigational Site | |
| Little Rock, Arkansas, United States | |
| United States, Florida | |
| 1160.46.01044 Boehringer Ingelheim Investigational Site | |
| Clearwater, Florida, United States | |
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| 1160.46.39007 Boehringer Ingelheim Investigational Site | |
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| Korea, Republic of | |
| 1160.46.82007 Boehringer Ingelheim Investigational Site | |
| Busan, Korea, Republic of | |
| 1160.46.82003 Boehringer Ingelheim Investigational Site | |
| Goyang-si, Korea, Republic of | |
| 1160.46.82010 Boehringer Ingelheim Investigational Site | |
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| 1160.46.60001 Boehringer Ingelheim Investigational Site | |
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| 1160.46.34009 Boehringer Ingelheim Investigational Site | |
| Madrid, Spain | |
| 1160.46.34015 Boehringer Ingelheim Investigational Site | |
| Palma de Mallorca, Spain | |
| 1160.46.34014 Boehringer Ingelheim Investigational Site | |
| Sabadell - barcelona, Spain | |
| 1160.46.34011 Boehringer Ingelheim Investigational Site | |
| Valencia, Spain | |
| Sweden | |
| 1160.46.46002 Boehringer Ingelheim Investigational Site | |
| Göteborg, Sweden | |
| 1160.46.46010 Boehringer Ingelheim Investigational Site | |
| Kristianstad, Sweden | |
| 1160.46.46001 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| 1160.46.46008 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| 1160.46.46003 Boehringer Ingelheim Investigational Site | |
| Uppsala, Sweden | |
| Taiwan | |
| 1160.46.88607 Boehringer Ingelheim Investigational Site | |
| ChangHua, Taiwan | |
| 1160.46.88609 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| 1160.46.88608 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| 1160.46.88606 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| 1160.46.88604 Boehringer Ingelheim Investigational Site | |
| Taipei, Taiwan | |
| Thailand | |
| 1160.46.66010 Boehringer Ingelheim Investigational Site | |
| Bangkok, Thailand | |
| 1160.46.66007 Boehringer Ingelheim Investigational Site | |
| Bangkok, Thailand | |
| 1160.46.66001 Boehringer Ingelheim Investigational Site | |
| Khon Kaen, Thailand | |
| 1160.46.66004 Boehringer Ingelheim Investigational Site | |
| Muang Nakhonratchasima, Thailand | |
| 1160.46.66005 Boehringer Ingelheim Investigational Site | |
| Nakhonratchasima, Thailand | |
| 1160.46.66006 Boehringer Ingelheim Investigational Site | |
| Nokorn Nayok, Thailand | |
| 1160.46.66008 Boehringer Ingelheim Investigational Site | |
| Phayathai, Thailand | |
| Turkey | |
| 1160.46.90003 Boehringer Ingelheim Investigational Site | |
| Ankara, Turkey | |
| 1160.46.90004 Boehringer Ingelheim Investigational Site | |
| Ankara, Turkey | |
| 1160.46.90010 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.46.90007 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.46.90008 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.46.90001 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.46.90002 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.46.90009 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| Ukraine | |
| 1160.46.38005 Boehringer Ingelheim Investigational Site | |
| Vinnitsa, Ukraine | |
| United Kingdom | |
| 1160.46.44005 Boehringer Ingelheim Investigational Site | |
| Headington, Oxford, United Kingdom | |
| 1160.46.44011 Boehringer Ingelheim Investigational Site | |
| London, United Kingdom | |
| 1160.46.44006 Boehringer Ingelheim Investigational Site | |
| Newcastle upon Tyne, United Kingdom | |
| 1160.46.44013 Boehringer Ingelheim Investigational Site | |
| Plymouth, United Kingdom | |
| 1160.46.44012 Boehringer Ingelheim Investigational Site | |
| Sheffield, United Kingdom | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00680186 History of Changes |
| Other Study ID Numbers: | 1160.46, 2007-002631-86 |
| Study First Received: | May 16, 2008 |
| Results First Received: | May 4, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Australia: Dept of Health and Ageing Therapeutic Goods Admin Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia Canada: Health Canada, Therapeutic Products Directorate China: Food and Drug Administration Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Denmark: Danish Medicines Agency France: AFSSAPS Great Britain: MHRA Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drugs Controller General of India Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Ethics Committee Korea, Republic of: Korea Drug and Food Administration Malaysia: National Pharmaceutical Control Bureau Netherlands: Central Committee Research Involving Human Subjects New Zealand: Multicentre Ethics Committee/Medsafe Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Philippines: Department of Health Poland: Registration Medicinal Product Medical Device Biocidal Product Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Singapore: Health Sciences Authority,Ministry of Health Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: MCC (Medicines Control Council) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency Taiwan: Department of Health Thailand: Ministry of Public Health Turkey: Ministry of Health Central Ethics Committee Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine) United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Thrombosis Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013