Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison Between Diuretics and Angiotensin-receptor Blocker Agents in Patients With Stage I Hypertension: PREVER-treatment Study
Brief Summary: High blood pressure is the major risk factor for Cardiovascular disease (CVD). The prevalence of hypertension in Brazil was established in population-based studies conducted in different cities and States, varying from 22.3 to 44% of adults.

The benefit of drug treatment of hypertension to prevent major cardiovascular events was consistently demonstrated in a large series of clinical trials controlled by placebo.

Diuretics are at least as efficacious as other blood pressure-lowering drugs, are well tolerated, have longer duration of action and the advantage of very low cost to be used in a population intervention. Chlorthalidone is the more efficacious agent. Its main limitation is to induce hypokalemia in a proportion of patients, an adverse effect that can be antagonized by a potassium-sparing diuretic, as amiloride.

A study comparing diuretic with an ARB agent is therefore recommendable in Brazil, in order to support the decisions of the Health Secretary in regard to blood pressure agents supply for the Brazilian population. Such a study was demanded and funded by the Health and Technology Ministries in Brazil.


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: Blood pressure variation and proportion of use of add-on drugs (18 months); Adverse events (18 months); Development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. (18 monyhs)
C: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)
D: Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy. (1 year)

Answer: B