Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel-Group, Cross-Over, 4-Period, 4 Treatment, Within-Subject Placebo-Controlled Study to Assess the Reno-Protective Effect of Renin Inhibition With Aliskiren as an Alternative to Irbesartan in Type 2 Patients With Incipient/Overt Diabetic Nephropathy
Brief Summary: This study will assess the reno-protective effect of renin inhibition with aliskiren as an alternative to irbesartan in type 2 diabetes patients with incipient/overt diabetic nephropathy.


Options:
A: 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))
B: To investigate whether renin-inhibition using aliskiren 300 mg daily could be a treatment alternative to the angiotensin II receptor antagonist irbesartan 300 mg with an equivalent potential for reno-protection
C: Change from baseline in diastolic blood pressure after 26 weeks
D: Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Answer: B