A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)

Exclusion Criteria

• •Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
• •* are not surgically sterile; and/or
• •* are nursing
• •* are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of ≥ 3-months duration. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
• •Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the placebo run-in period
• •Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• •* Serum glutamate-pyruvate-transaminase (alanine aminotransferase) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) greater than two times the upper limit of normal
• •* Serum creatinine \> 2.3 mg/dL
• •Clinically relevant sodium depletion, hyperkalemia, or hypokalemia
• •Uncorrected volume depletion
• •Primary aldosteronism
• •Biliary obstructive disorders
• •Known or suspected secondary hypertension
• •Hereditary fructose intolerance
• •Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
• •Congestive heart failure (NYHA functional class congestive heart failure (CHF) class III-IV)
• •Unstable angina within the past three months
• •Stroke within the past six months
• •Myocardial infarction or cardiac surgery within the past three months
• •Percutaneous transluminal coronary angioplasty (PTCA) within the past three months
• •History of angioedema
• •Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
• •Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
• •Patients with insulin-dependent diabetes mellitus whose diabetes hast not been stable and controlled for at least the past three months as defined by an HbA1c ≥ 10%
• •Known drug or alcohol dependency within the past 6 months
• •Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
• •Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridien (AM)
• •Patients receiving any investigational therapy within one month of signing the informed consent form
• •Known hypersensitivity to any component of the formulations
• •Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication