Notes:

  1. Year 4 or final visit.
  2. If tests performed or medication discontinued with the intent to participate in the study.
  3. DBP 95-115 or SBP 160-200 at 2 consecutive visits separated by at least 1 week for continued eligibility.
  4. Standing BP and heart rate if study drug upward titrated.
  5. Glucose retesting for evaluation of new-onset diabetes mellitus.
  6. Glucose and creatinine only.
  7. Sodium, potassium, and creatinine only.
  8. ECG within past year.
  9. Within 30 days prior to Visit 1 and sent to ECG Core Center for evaluation of LVH.
  10. Patients could remain on placebo for up to 28 days to qualify for elevated BP as in c).
  11. The last placebo tablet should have been taken the previous morning.
  12. BP control was titrated as described under Duration and Adjustment of Treatment below.
  13. As specified in Standard Operating Procedures and worksheets.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure 13: Reviewer’s Kaplan-Meier Plot of Primary Composite Endpoint in Blacks

 

Figure 14: Reviewer’s Kaplan-Meier Plot of Strokes in Blacks

Figure 15: Reviewer’s Kaplan-Meier Plot of Myocardial Infarctions in Blacks

Figure 16: Reviewer’s Kaplan-Meier Plot of CV Mortality in Blacks

Figure 17: Reviewer’s Kaplan-Meier Plot of Total Mortality in Blacks