Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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.
Brief Summary: 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.


Options:
A: Arm Label: Dabigatran 110 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran 110 mg | Arm Label: Dabigatran 150 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran 150 mg | Arm Label: Unfractionated Heparin; Type: ACTIVE_COMPARATOR; Interventions: Drug: unfractionated heparin | Intervention Type: DRUG; Name: dabigatran 110 mg; Assigned to Arm(s): Dabigatran 110 mg | Intervention Type: DRUG; Name: dabigatran 150 mg; Assigned to Arm(s): Dabigatran 150 mg | Intervention Type: DRUG; Name: unfractionated heparin; Assigned to Arm(s): Unfractionated Heparin
B: Arm Label: dabigatran etexilate 150 mg; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate 150 mg | Arm Label: warfarin (INR 2-3); Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin (INR 2-3) | Intervention Type: DRUG; Name: dabigatran etexilate 150 mg; Assigned to Arm(s): dabigatran etexilate 150 mg | Intervention Type: DRUG; Name: warfarin (INR 2-3); Assigned to Arm(s): warfarin (INR 2-3)
C: Arm Label: Dabigatran etexilate; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate intermediate dose, Drug: dabigatran etexilate low dose, Drug: dabigatran etexilate high dose | Arm Label: warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin 1mg, Drug: warfarin 5mg, Drug: warfarin 3mg | Intervention Type: DRUG; Name: warfarin 1mg; Assigned to Arm(s): warfarin | Intervention Type: DRUG; Name: dabigatran etexilate intermediate dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: dabigatran etexilate low dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: warfarin 5mg; Assigned to Arm(s): warfarin | Intervention Type: DRUG; Name: dabigatran etexilate high dose; Assigned to Arm(s): Dabigatran etexilate | Intervention Type: DRUG; Name: warfarin 3mg; Assigned to Arm(s): warfarin
D: Arm Label: dabigatran etexilate 150 mg BID; Type: EXPERIMENTAL; Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID) | Arm Label: matching placebo twice daily (BID); Type: PLACEBO_COMPARATOR; Interventions: Drug: matching placebo twice daily (BID) | Intervention Type: DRUG; Name: dabigatran etexilate 150 mg twice daily (BID); Assigned to Arm(s): dabigatran etexilate 150 mg BID | Intervention Type: DRUG; Name: matching placebo twice daily (BID); Assigned to Arm(s): matching placebo twice daily (BID)

Answer: B