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

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