An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Olmesartan medoxomil; Olmesartan medoxomil/hydrochlorothiazide
Intervention description: Tablets; Tablets
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Hypertension; Angiotensin Receptor Blocker; Calcium Channel Blocker; Angiotensin Converting Enzyme Inhibitor; Hydrochlorothiazide; Stage I and II Hypertension

Summary:

      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.
    

Eligibility criteria:

        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.