An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Inclusion criteria

• 1. 18 years of age.
• 2. Patients with stage II systolic hypertension
• 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, 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

• 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.

• History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.

• Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).

• History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.

• Type I diabetes mellitus. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.

• Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter.

• Laboratory test values considered clinically significant by the investigator.

• Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.

• Pregnant or lactating females.
• 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.