Olmesartan and an add-on Treatment in Patients With Mild to Moderate Hypertension (OLMETREAT)

Inclusion Criteria: Male and female patients age greater than or equal to 18 years with mild to moderate hypertension. Pre-treated patients with normal or elevated blood pressure (BP) are eligible to participate if their pre-treatment medication can be withdrawn. At the end of the placebo run-in period sitting systolic BP greater than or equal to 140 and less than 180 mmHg and/or sitting diastolic BP greater than or equal to 90 and less than 110 mmHg at trough. Exclusion Criteria: Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/oncological, neurological and psychiatric diseases. Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack. Patients with clinically significant elevations in laboratory values at Screening Visit. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome. Patients with contraindications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.