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 clinical trial was to show that the combination of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg was not inferior to and was possibly superior to amlodipine 10 mg + HCTZ 12.5 mg in reducing the systolic blood pressure (SBP) in the last six hours of the 24-hour dose period [as measured by 24-hour ambulatory blood pressure monitoring ( ABPM)] in elderly patients with predominantly systolic hypertension. The primary endpoint was the change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM) at the end-of-study visit.

• Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
• Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg

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