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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 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.
- 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.
|Study Start Date:||November 2002|
|Estimated Study Completion Date:||March 2004|
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|Study Chair:||Boehringer Ingelheim Study Coordinator||BIL UK / Ireland|