Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
Brief Summary: The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.


Options:
A: Intervention Type: DRUG; Name: aliskiren; Assigned to Arm(s): N/A
B: Arm Label: Aliskiren + Amlodipine; Type: EXPERIMENTAL; Interventions: Drug: Aliskiren, Drug: Amlodipine | Arm Label: Aliskiren + Hydrochlorothiazide (HCTZ); Type: EXPERIMENTAL; Interventions: Drug: Aliskiren, Drug: Hydrochlorothiazide (HCTZ) | Arm Label: Aliskiren + Placebo for Amlodipine; Type: EXPERIMENTAL; Interventions: Drug: Aliskiren, Drug: Placebo for Amlodipine | Arm Label: Aliskiren + Placebo for HCTZ; Type: EXPERIMENTAL; Interventions: Drug: Aliskiren, Drug: Placebo for Hydrochlorothiazide (HCTZ) | Arm Label: Amlodipine + Placebo for Aliskiren; Type: EXPERIMENTAL; Interventions: Drug: Amlodipine, Drug: Placebo for Aliskiren | Arm Label: HCTZ + Placebo for Aliskiren; Type: EXPERIMENTAL; Interventions: Drug: Hydrochlorothiazide (HCTZ), Drug: Placebo for Aliskiren | Arm Label: Placebo for Aliskiren + Placebo for Amlodipine; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for Aliskiren, Drug: Placebo for Amlodipine | Arm Label: Placebo for Aliskiren + Placebo for HCTZ; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for Aliskiren, Drug: Placebo for Hydrochlorothiazide (HCTZ) | Intervention Type: DRUG; Name: Aliskiren; Assigned to Arm(s): Aliskiren + Amlodipine, Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + Placebo for Amlodipine, Aliskiren + Placebo for HCTZ | Intervention Type: DRUG; Name: Amlodipine; Assigned to Arm(s): Aliskiren + Amlodipine, Amlodipine + Placebo for Aliskiren | Intervention Type: DRUG; Name: Hydrochlorothiazide (HCTZ); Assigned to Arm(s): Aliskiren + Hydrochlorothiazide (HCTZ), HCTZ + Placebo for Aliskiren | Intervention Type: DRUG; Name: Placebo for Aliskiren; Assigned to Arm(s): Amlodipine + Placebo for Aliskiren, HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine, Placebo for Aliskiren + Placebo for HCTZ | Intervention Type: DRUG; Name: Placebo for Amlodipine; Assigned to Arm(s): Aliskiren + Placebo for Amlodipine, Placebo for Aliskiren + Placebo for Amlodipine | Intervention Type: DRUG; Name: Placebo for Hydrochlorothiazide (HCTZ); Assigned to Arm(s): Aliskiren + Placebo for HCTZ, Placebo for Aliskiren + Placebo for HCTZ
C: Arm Label: Aliskiren; Type: EXPERIMENTAL; Interventions: Drug: Aliskiren | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aliskiren; Assigned to Arm(s): Aliskiren | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aliskiren | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aliskiren; Assigned to Arm(s): 2

Answer: C