A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00291330Tipo: INTERVENTIONALInicio: 1 de feb de 2006

Traducción no disponible, mostrando original

Resumen

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
Male or female, being 18 years of age or older
Written informed consent for study participation

Criterios de exclusión

Overt symptoms of VTE for longer than 2 weeks prior to enrolment
PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
Actual or anticipated use of vena cava filter
Contraindications to anticoagulant therapy
Patients who in the investigators opinion should not be treated with warfarin
Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
Known anaemia
Need of anticoagulant treatment for disorders other than VTE
Recent unstable cardiovascular disease
Elevated AST or ALT \> 2x ULN
Liver disease expected to have any potential impact on survival
Patients who have developed transaminase elevations upon exposure to ximelagatran
Severe renal impairment
Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
Patients considered unsuitable for inclusion by the investigator

Intervenciones

drug

dabigatran etexilate 150 mg

twice daily

drug

warfarin (INR 2-3)

prn to maintain INR (2-3)

Ubicaciones

1160.53.54017 Boehringer Ingelheim Investigational Site

Adrogué, Argentina

1160.53.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1160.53.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1160.53.54006 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1160.53.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

1160.53.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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