Please select the outcome measures that correspond 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: Change from baseline in diastolic blood pressure after 8 weeks
B: Number of Participants With Composite Cardiovascular Endpoints in Aliskiren Based Regimen Versus Non-Aliskiren Based Regimen (End of study (209 days (median))); Number of Participants With Composite Cardiovascular Endpoints in Aliskiren+Amlodipine/HCTZ Group Versus All Placebo Group (End of study (209 days (median)))
C: Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 Months)); Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase) (Time from randomization to the first event (Maximum 50 months)); Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Cardiovascular (CV) Death (Extension Phase) (from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Resuscitated Sudden Death (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)); Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase) (From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)); Percentage of Participants With All Cause Mortality (Extension Phase) (from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average))
D: Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment (Baseline, 104 weeks)

Answer: C