Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Inclusion criteria

• Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
• Age 18 years or older;
• Patients with grade 2 or grade 3 hypertension as defined SBP>=160 mmHg and DBP>=100 mmHg at randomization
• Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Exclusion criteria

• Pre-menopausal women (last menstruation = 200 mmHg and/or DBP >=120 mmHg
• Renal dysfunction as defined by the following laboratory parameters: Serum creatinine >3.0 mg/dL (or >265 umol/L) and/or known creatinine clearance of 5.5 mmol/L, may be rechecked for suspected error in result)
• Uncorrected sodium or volume depletion
• Primary aldosteronism.
• Hereditary fructose intolerance
• Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency
• Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.3)
• Contra-indication to a placebo run-in period (e.g., stroke with-in the past 6 months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past 3 months prior to start of run in period)
• Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
• Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
• Patients whose diabetes has not been stable and controlled for at least the past 3 months as defined by an Glycosylated Hemoglobin >=10%
• Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists
• History of drug or alcohol dependency within 6 months prior to signing the informed consent form
• Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
• Any investigational drug therapy within 1 month of signing the informed consent
• Known hypersensitivity to any component of the trial drugs (telmisartan, hydrochlorothiazide, or placebo)
• History of non-compliance or inability to comply with prescribed medications or protocol procedures (less than 80% or more than 120%, especially during run-in)
• Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication