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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg

Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240474

502.400

Details and patient eligibility

About

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.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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