A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)

Inclusion criteria:

• aged at least 60 years old
• mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg
• 24-hour mean ambulatory SBP greater than 125 mmHg
• hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
• willing and able to provide written informed consent

Exclusion criteria:

• women of child-bearing potential who are NOT practicing acceptable means of birth control
• known or suspected secondary hypertension
• mean SBP equal to or greater than 200 mmHg

• 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
• primary aldosteronism
• hereditary fructose intolerance
• biliary obstructive disorders
• 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 the previous six months
• chronic administration of any medication known to affect blood pressure, other than the trial medication
• concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
• symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
• unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
• stroke less than six months prior to informed consent
• sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
• hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
• insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
• night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
• known allergic hypersensitivity to any component of the formulations under investigation
• concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as less than 80% or more than 120%) during the run-in period
• current treatment with any antihypertensive agent
• 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