a comparison of telmisartan + hydrochlorothiazide with amlodipine + hydrochlorothiazide in the control of blood pressure in older patients with predominantly systolic hypertension (athos study)

Conditions: Hypertension

Summary: the primary objective of this study was test non-inferiority of telmisartan 80 mg + hydrochlorothiazide (hctz) 12.5 mg in comparison to amlodipine 10 mg + hctz 12.5 mg in reducing ambulatory systolic blood pressure (sbp) in the last 6 hours of the 24-hour dosing interval (determined by ambulatory blood pressure monitoring: abpm) in elderly patients with predominantly systolic hypertension.


Eligibility criteria:
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