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

A Comparison of Telmisartan 80 mg + Hydrochlorothiazide 12.5 mg With Amlodipine 10 mg + Hydrochlorothiazide 12.5 mg in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension. A Prospective, Randomised, Open-label, Blinded End-point Evaluation. (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.

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