A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

This study was to randomize an equal number of participants to either an olmesartan medoxomil
based treatment or to placebo. The titration scheme was as follows:

- First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo

- Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil
40 mg or placebo

- Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil
40 mg/HCT 12.5 mg or placebo

- Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil
40 mg/HCT 25 mg or placebo

- Subjects with a mean BP of <120/80 mmHg at any visit were considered responders and were
not titrated up to the next dose level. However, they remained in the study at their
currently assigned dose of study medication.

- Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any
subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose
level according to the titration scheme above.

- Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained
on that dose until study exit at Visit 8, unless safety concerns caused discontinuation
of treatment.

Inclusion Criteria:

- Greater than or equal to 18 years of age.

- Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to
140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure
(MSDBP) less than or equal to 109 mmHg following a 3 to 4-week single-blind placebo
run-in period.

- The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less
than or equal to 10 mmHg.

- Patients with a mean daytime (8AM-4PM) systolic blood pressure (SBP) greater than or
equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic
blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood
pressure monitoring device (ABPM) following placebo run-in period.

- If female, must have negative serum pregnancy test at screening and be either
post-menopausal (greater than or equal to 1 year), had a hysterectomy or tubal
ligation at least 6 months before consent or if of childbearing potential, must
practice approved measures of birth control throughout study.

Exclusion Criteria:

- History of stroke or transient ischemic attack (TIA) within the last one year.

- History of myocardial infarction, coronary angioplasty, coronary artery bypass graft,
or heart failure within the past 6 months.

- Patients with secondary hypertension of any etiology, such as renal disease,
pheochromocytoma, or Cushing's syndrome.

- Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting
glucose <160 mg/dl may enroll.

- Patients with hemodynamically significant cardiac valvular disease.

- Patients with clinically significant cardiac conduction defects, including first,
second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial
fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring
medication.