Eligibility NCT00240474 Hypertension Inclusion Criteria Exclusion Criteria women of child-bearing potential who are NOT practicing acceptable means of birth control Yes
No
known or suspected secondary hypertension Yes
No
mean SBP >=200 mmHg Yes
No
hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion. Yes
No
Primary aldosteronism, unspecified Yes
No
Hereditary fructose intolerance syndrome Yes
No
Biliary Obstruction Yes
No
patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists Yes
No
history of drug or alcohol dependency within the previous six months Yes
No
chronic administration of any medication known to affect blood pressure, other than the trial medication Yes
No
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form. Yes
No
symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV) Yes
No
unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent Yes
No
stroke <6 months prior to informed consent Yes
No
sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator Yes
No
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve Yes
No
insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months Yes
No
night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM Yes
No
known allergic hypersensitivity to any component of the formulations under investigation Yes
No
concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period Yes
No
current treatment with any antihypertensive agent Yes
No
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide Yes
No
