Official Title: “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 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

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

Primary Measures

• The primary endpoint variable was the ambulatory SBP in the last six hours of the dosing interval at the end-of-study visit compared with the ambulatory SBP in the last six hours of the dosing interval at the baseline visit.

Secondary Measures

• Ambulatory DBP, pulse pressure in the last 6 hours of the dosing interval, ambulatory SBP, DBP and pulse pressure at other times of day, proportion of patients achieving SBP control, SBP response and normal blood pressure.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair BIL UK / Ireland  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00240474

Study ID Number: 502.400

ClinicalTrials.gov Identifier: NCT00240474

Health Authority: Belgium: Directorate General for Medicinal Products