An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

• Change from baseline in Systolic BP (SBP) after 12 weeks of active treatment
• as measured by 24-hour ABPM.

• Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]
• Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]

• Change from baseline in mean 24-hour ABPM Diastolic BP (DBP) after 12 weeks
• of active treatment. Change from baseline in mean daytime (8am-4pm) and
• mean nightime (10 pm-6am) ABPM SBP and DBP after 12 weeks of active
• treatment.
• Incremental cuff BP change between each tritration step.
• Number and percentage of patients achieving SBP drop in the following
• categories: drop less than or equal to 15 mmHg; 15 less than drop less
• than or equal to 30 mmHg;; 30 less than drop less than or equal to 45 mmHg;
• drop greater than 45 mmHG.

This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

• Drug: Olmesartan medoxomil
  Tablets
• Drug: Olmesartan medoxomil/hydrochlorothiazide
  Tablets

Inclusion Criteria:

1. Males or Females greater than 65 years of age
2. Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
3. The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg.
4. Patients with a mean daytime (8am-4pm) systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than or equal to 199 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.

Exclusion Criteria:

1. History of stroke or transient ischemic attack (TIA) within the last one year.
2. History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
3. Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg).
4. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome.
5. Type I diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
8. Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.