Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00329238
First received: May 23, 2006
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.
| Condition | Intervention | Phase |
|---|---|---|
|
Thromboembolism |
Drug: Dabigatran Drug: Warfarin |
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, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism. |
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:
- Hazard Ratio for Composite of Recurrent VTE or VTE Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to First Adjucated Recurrent VTE or VTE Death at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. Risk differences were estimated using standard Kaplan-Meier estimates.
Secondary Outcome Measures:
- Hazard Ratio for Composite of Recurrent VTE or All Cause Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to First Adjucated Recurrent VTE or All Cause Death at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. Risk differences were estimated using standard Kaplan-Meier estimates.
- Hazard Ratio for Deep Vein Thrombosis (DVT) During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for deep vein thrombosis. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to First Adjucated Recurrent Symptomatic DVT at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for time to first adjucated recurrent symptomatic DVT. Risk differences were estimated using standard Kaplan-Meier estimates.
- Hazard Ratio for Symptomatic Pulmonary Embolism (PE) During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for symptomatic pulmonary embolism. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to First Adjucated Recurrent Symptomatic Pulmonary Embolism at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for time to first adjucated recurrent symptomatic pulmonary embolism. Risk differences were estimated using standard Kaplan-Meier estimates.
- Hazard Ratio for Time to Deaths Related to VTE During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for deaths related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to Deaths Related to VTE at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for time to deaths related to VTE. Risk differences were estimated using standard Kaplan-Meier estimates.
- Hazard Ratio for Time to Deaths of All Causes During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]Hazard ratio of dabigatran versus warfarin for deaths related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.
- Risk Difference for Time to Deaths of All Causes at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]Risk difference of dabigatran versus warfarin at 18 months for time to deaths of all causes. Risk differences were estimated using standard Kaplan-Meier estimates.
| Enrollment: | 2867 |
| Study Start Date: | May 2006 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
|
Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
|
|
Active Comparator: Warfarin (INR of 2.0-3.0)
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
|
Drug: Warfarin
Warfarin dosed individually to maintain INR 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:
Inclusion_Criteria
- Acute symptomatic deep vein thrombosis (DVT)
- Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing
Exclusion criteria:
Exclusion_Criteria
- Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
- Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
- Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329238
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| Rotterdam, Netherlands | |
| New Zealand | |
| 1160.47.64004 Boehringer Ingelheim Investigational Site | |
| Christchurch, New Zealand | |
| 1160.47.64003 Boehringer Ingelheim Investigational Site | |
| Grafton, New Zealand | |
| 1160.47.64002 Boehringer Ingelheim Investigational Site | |
| Otahuhu, New Zealand | |
| 1160.47.64001 Boehringer Ingelheim Investigational Site | |
| Takapuna Auckland 9, New Zealand | |
| Norway | |
| 1160.47.47004 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1160.47.47001 Boehringer Ingelheim Investigational Site | |
| Oslo, Norway | |
| 1160.47.47003 Boehringer Ingelheim Investigational Site | |
| Rud, Norway | |
| 1160.47.47005 Boehringer Ingelheim Investigational Site | |
| Trondheim, Norway | |
| Poland | |
| 1160.47.48004 Boehringer Ingelheim Investigational Site | |
| Kielce, Poland | |
| 1160.47.48007 Boehringer Ingelheim Investigational Site | |
| Krakow, Poland | |
| 1160.47.48005 Boehringer Ingelheim Investigational Site | |
| Krakow, Poland | |
| 1160.47.48003 Boehringer Ingelheim Investigational Site | |
| Poznan, Poland | |
| 1160.47.48006 Boehringer Ingelheim Investigational Site | |
| Warsaw, Poland | |
| Portugal | |
| 1160.47.35104 Boehringer Ingelheim Investigational Site | |
| Almada, Portugal | |
| 1160.47.35109 Boehringer Ingelheim Investigational Site | |
| Coimbra, Portugal | |
| 1160.47.35107 Boehringer Ingelheim Investigational Site | |
| Covilhã, Portugal | |
| 1160.47.35105 Boehringer Ingelheim Investigational Site | |
| Lisboa, Portugal | |
| 1160.47.35102 Boehringer Ingelheim Investigational Site | |
| Lisboa, Portugal | |
| 1160.47.35101 Boehringer Ingelheim Investigational Site | |
| Lisboa, Portugal | |
| Russian Federation | |
| 1160.47.07022 Boehringer Ingelheim Investigational Site | |
| Belgorod, Russian Federation | |
| 1160.47.07011 Boehringer Ingelheim Investigational Site | |
| Chelyabinsk, Russian Federation | |
| 1160.47.07021 Boehringer Ingelheim Investigational Site | |
| Chelyabinsk, Russian Federation | |
| 1160.47.07007 Boehringer Ingelheim Investigational Site | |
| Ekaterinburg, Russian Federation | |
| 1160.47.07016 Boehringer Ingelheim Investigational Site | |
| Krasnodar, Russian Federation | |
| 1160.47.07004 Boehringer Ingelheim Investigational Site | |
| Kursk, Russian Federation | |
| 1160.47.07010 Boehringer Ingelheim Investigational Site | |
| Novosibirsk, Russian Federation | |
| 1160.47.07020 Boehringer Ingelheim Investigational Site | |
| Omsk, Russian Federation | |
| 1160.47.07018 Boehringer Ingelheim Investigational Site | |
| Pskov, Russian Federation | |
| 1160.47.07023 Boehringer Ingelheim Investigational Site | |
| Rostov-na-Donu, Russian Federation | |
| 1160.47.07024 Boehringer Ingelheim Investigational Site | |
| Rostov-na-Donu, Russian Federation | |
| 1160.47.07025 Boehringer Ingelheim Investigational Site | |
| Rostov-na-Donu, Russian Federation | |
| 1160.47.07009 Boehringer Ingelheim Investigational Site | |
| Rostov-na-Donu, Russian Federation | |
| 1160.47.07017 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1160.47.07001 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1160.47.07002 Boehringer Ingelheim Investigational Site | |
| St. Petersburg, Russian Federation | |
| 1160.47.07019 Boehringer Ingelheim Investigational Site | |
| Tyumen, Russian Federation | |
| 1160.47.07014 Boehringer Ingelheim Investigational Site | |
| Ufa, Russian Federation | |
| 1160.47.07005 Boehringer Ingelheim Investigational Site | |
| Yaroslavl, Russian Federation | |
| 1160.47.07006 Boehringer Ingelheim Investigational Site | |
| Yaroslavl, Russian Federation | |
| Slovakia | |
| 1160.47.42107 Boehringer Ingelheim Investigational Site | |
| Banska Bystrica, Slovakia | |
| 1160.47.42106 Boehringer Ingelheim Investigational Site | |
| Lucenec, Slovakia | |
| 1160.47.42102 Boehringer Ingelheim Investigational Site | |
| Nitra, Slovakia | |
| 1160.47.42103 Boehringer Ingelheim Investigational Site | |
| Nove Zamky, Slovakia | |
| 1160.47.42104 Boehringer Ingelheim Investigational Site | |
| Zilina, Slovakia | |
| South Africa | |
| 1160.47.27002 Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa | |
| 1160.47.27001 Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa | |
| 1160.47.27006 Boehringer Ingelheim Investigational Site | |
| Johannesburg, South Africa | |
| 1160.47.27007 | |
| Pretoria, South Africa | |
| 1160.47.27003 Boehringer Ingelheim Investigational Site | |
| Randburg, South Africa | |
| 1160.47.27005 Boehringer Ingelheim Investigational Site | |
| Roodepoort, South Africa | |
| Spain | |
| 1160.47.34006 Boehringer Ingelheim Investigational Site | |
| Alicante, Spain | |
| 1160.47.34012 Boehringer Ingelheim Investigational Site | |
| Badalona (Barcelona), Spain | |
| 1160.47.34002 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1160.47.34001 Boehringer Ingelheim Investigational Site | |
| Barcelona, Spain | |
| 1160.47.34007 Boehringer Ingelheim Investigational Site | |
| Cartagena. Murcia, Spain | |
| 1160.47.34003 Boehringer Ingelheim Investigational Site | |
| Cuenca, Spain | |
| 1160.47.34009 Boehringer Ingelheim Investigational Site | |
| Madrid, Spain | |
| 1160.47.34004 Boehringer Ingelheim Investigational Site | |
| Santander, Spain | |
| 1160.47.34011 Boehringer Ingelheim Investigational Site | |
| Valencia, Spain | |
| Sweden | |
| 1160.47.46002 Boehringer Ingelheim Investigational Site | |
| Göteborg, Sweden | |
| 1160.47.46006 Boehringer Ingelheim Investigational Site | |
| Jönköping, Sweden | |
| 1160.47.46008 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| 1160.47.46007 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| 1160.47.46001 Boehringer Ingelheim Investigational Site | |
| Stockholm, Sweden | |
| 1160.47.46005 Boehringer Ingelheim Investigational Site | |
| Sundsvall, Sweden | |
| 1160.47.46003 Boehringer Ingelheim Investigational Site | |
| Uppsala, Sweden | |
| Turkey | |
| 1160.47.90005 Boehringer Ingelheim Investigational Site | |
| Ankara, Turkey | |
| 1160.47.90004 Boehringer Ingelheim Investigational Site | |
| Ankara, Turkey | |
| 1160.47.90003 Boehringer Ingelheim Investigational Site | |
| Ankara, Turkey | |
| 1160.47.90001 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.47.90007 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.47.90002 Boehringer Ingelheim Investigational Site | |
| Istanbul, Turkey | |
| 1160.47.90006 Boehringer Ingelheim Investigational Site | |
| Izmir, Turkey | |
| Ukraine | |
| 1160.47.38002 Boehringer Ingelheim Investigational Site | |
| Kharkov, Ukraine | |
| 1160.47.38006 Boehringer Ingelheim Investigational Site | |
| Kiev, Ukraine | |
| 1160.47.38005 Boehringer Ingelheim Investigational Site | |
| Vinnitsa, Ukraine | |
| 1160.47.38003 Boehringer Ingelheim Investigational Site | |
| Zaporozhye, Ukraine | |
| United Kingdom | |
| 1160.47.44005 Boehringer Ingelheim Investigational Site | |
| Headington, Oxford, United Kingdom | |
| 1160.47.44011 Boehringer Ingelheim Investigational Site | |
| London, United Kingdom | |
| 1160.47.44009 Boehringer Ingelheim Investigational Site | |
| London, United Kingdom | |
| 1160.47.44006 Boehringer Ingelheim Investigational Site | |
| Newcastle upon Tyne, United Kingdom | |
| 1160.47.44012 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 by Boehringer Ingelheim Pharmaceuticals
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00329238 History of Changes |
| Other Study ID Numbers: | 1160.47, 2005-002536-94 |
| Study First Received: | May 23, 2006 |
| Results First Received: | August 10, 2011 |
| Last Updated: | February 28, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Dept of Health and Ageing Therapeutic Goods Admin Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna Belgium: Federal Agency for Medicines and Health Products Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia Canada: Health Canada, Therapeutic Products Directorate China: Ministry of Health Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Denmark: The Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: BfArM-Federal Authorities for Drugs and Medical Devices Great Britain: MHRA Greece: National Organization for Medicines (EOF) National Ethics Committee Hungary: National Institute of Pharmacy, H-1051 Budapest India: Drug Control General of India Israel: Israeli Health Ministry Pharmaceutical Administration Italy: Comitato Etico delle Aziende Sanitarie dell'Umbria di Perugia Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS Federal Commission for Protection against Sanitary Hazards Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Multicentre Ethics Committee/Medsafe Norway: Norwegian Medicines Agency (Statens Legemiddelverk) Poland: Registration Medicinal Product Medical Device Biocidal Product Portugal: INFARMED - National Authority of Medicines and Health Products, IP Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 South Africa: Medicines Control Council Spain: Spanish Agency for Medicines and Health Products Sweden: Medical Products Agency Regional Ethical Review Board 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 16, 2013