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


Options:
A: 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)
B: Arm Label: Warfarin/placebo edoxaban; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin tablets, Drug: placebo edoxaban | Arm Label: high dose edoxaban/placebo warfarin; Type: EXPERIMENTAL; Interventions: Drug: Edoxaban tablets (high dose regimen-60mg), Drug: placebo warfarin | Arm Label: low dose edoxaban/placebo warfarin; Type: EXPERIMENTAL; Interventions: Drug: Edoxaban tablets (low dose regimen-30mg), Drug: placebo warfarin | Intervention Type: DRUG; Name: warfarin tablets; Assigned to Arm(s): Warfarin/placebo edoxaban | Intervention Type: DRUG; Name: Edoxaban tablets (high dose regimen-60mg); Assigned to Arm(s): high dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: Edoxaban tablets (low dose regimen-30mg); Assigned to Arm(s): low dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: placebo warfarin; Assigned to Arm(s): high dose edoxaban/placebo warfarin, low dose edoxaban/placebo warfarin | Intervention Type: DRUG; Name: placebo edoxaban; Assigned to Arm(s): Warfarin/placebo edoxaban
C: Arm Label: Dabigatran dose 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dabigatran dose 2 | Arm Label: Warfarin; Type: ACTIVE_COMPARATOR; Interventions: Drug: warfarin | Arm Label: Dabigatran dose 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dabigatran dose 1 | Intervention Type: DRUG; Name: warfarin; Assigned to Arm(s): Warfarin | Intervention Type: DRUG; Name: Dabigatran dose 1; Assigned to Arm(s): Dabigatran dose 1 | Intervention Type: DRUG; Name: Dabigatran dose 2; Assigned to Arm(s): Dabigatran dose 2
D: Arm Label: Dabigatran; Type: EXPERIMENTAL; Interventions: Drug: Dabigatran | Arm Label: Warfarin (INR of 2.0-3.0); Type: ACTIVE_COMPARATOR; Interventions: Drug: Warfarin | Intervention Type: DRUG; Name: Dabigatran; Assigned to Arm(s): Dabigatran | Intervention Type: DRUG; Name: Warfarin; Assigned to Arm(s): Warfarin (INR of 2.0-3.0)

Answer: D