HREC Ref

Trial Project

05145A

BOTTICELLI

A phase 2 randomised, parallel-arm study of oral direct Faxtor Xa-inhibitor Apixaban and low molecular weight Heparin or Fondaparinux with a vitamin K antagonist in subjects with acute symptomatic deep-vein thrombosis

05185A

RECOVER

A phase 3, randomised, double-blind, parallel-group study of the efficacy and safety of oral dabigatran etexilate (150mg bid) compared to warfarin (INR 2.0-3.0) for six months treatment of acute symptomatic venous thromboembolism, following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication.

05186A

REMEDY

A phase 3, randomised, multicentre double-blind, parallel-group, active controlled study to evaluate the efficacy and safety of oral dabigatran etexilate (150mg bid), compared to warfarin (INR 2.0-3.0), for the secondary prevention of venous thromboembolism.

06028A

Pfizer

Prophylaxis of VTE in TKNR using PD 0348292

06026A

EQUINOX

International, multicentre, randomized, parallel-group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at stead state of equimolar doses of SSR`126517E (3.0mg) once a week end SR34006 (2.5mg) once a week, documenting the safety and efficacy of both compounds during a 6-month treatment, and demonstrating the neutralizing effect of SSR29261 on the SSR126517E induced anti-X1 activity.

06025A

TOPVENT

Prophylaxis in TKJR

06005A

RECORD1

Prophylaxis of VTE in THJR using BAY 597939

03008A

ASPIRE

A multi-centre, randomized, double-blind, placebo-controlled, phase 3 clinical trial examining the efficacy and safety of low-dose aspirin after initial anticoagulation to prevent recurrent venous thromboembolism.

06095A

CASSIOPEA

An international, multicentre, randomized, double-blind, double-dummy, parallel group, phase III study to evaluate whether a 3-month or 6-month treatment with once weekly SSR126517E s.c. injections is at least as effective as a 3- or 6-month treatment with oral INR-adjusted warfarin in patients with symptomatic pulmonary embolism, with or without symptomatic deep vein thrombosis.