3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension

Exclusion Criteria

• •1. Known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, melanocytoma, etc.).
• •2. Mean supine DBP \> 114 mmHg and/or mean supine SBP \> 200 mmHg during any visit of the placebo run-in period.
• •3. Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias (atrioventricular conduction disturbance (grade II - III), atrial fibrillation etc.).
• •4. NYHA functional class heart failure III-IV.
• •5. Myocardial infarction or cardiac surgery within 6 months of signing the informed consent form.
• •6. Coronary artery bypass surgery or percutaneous transluminal coronary angioplasty (PTCA) within 3 months of signing the informed consent form.
• •7. Unstable angina within 3 months of signing the informed consent form.
• •8. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
• •9. Stroke or transient ischemic attack within 6 months of signing the informed consent form.
• •10. History of sudden exacerbation of renal function with AT1 receptor antagonists or ACE inhibitors; post-renal transplant.
• •11. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, laryngeal swelling with dyspnea) during treatment with AT1 receptor antagonists or ACE inhibitors.
• •12. Known hypersensitivity to any component of the formulation, or a known hypersensitivity to sulfonamides or sulphonamide-derived drugs (e.g. thiazides).
• •13. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• •* SGPT(ALT) or SGOT(AST) \>= 2 times the upper limit of normal at screening (Visit 1).
• •* Patients who have markedly poor bile secretion by the following laboratory parameters: Patients whose direct bilirubin \>= 2.0 mg/dL at screening (Visit 1).
• •* Serum creatinine \>= 2.1 mg/dL at screening (Visit 1).