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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
* Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg|nan|
|Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the last 6-hour mean (relative to dose time) in SBP as measured by 24-hour ABPM at the end-of-study visit |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in DBP in the last six hours of the 24-hour dose period |  | week 8 and 14 | 
| Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period |  | week 8 and 14 | 
| Change from baseline SBP and DBP for other time intervals ( i.e. 24-hour mean, morning mean (06:00-11:59), daytime mean (06:00-21:59), and night-time mean (22:00-05:59)) |  | week 8 and 14 | 
| Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. |  | week 8 and 14 | 
| Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM). |  | 8 weeks | 
| Proportion of patients achieving a target response in SBP |  | 14 weeks | 
| Proportion of patients achieving SBP control |  | 14 weeks | 
| Proportion of patients achieving normal blood pressure |  | 14 weeks | 
| Proportion of patients achieving high-normal blood pressure |  | 14 weeks | 
| Change from baseline in trough seated SBP |  | 14 weeks | 
| Change from baseline in trough seated DBP |  | 14 weeks | 
| Safety and tolerability of the combination of telmisartan 80 mg and HCTZ 12.5 mg compared with amlodipine 10 mg and HCTZ 12.5 mg |  | 14 weeks |