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

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00240474
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of patients achieving a target response in SBP	14 weeks
Proportion of patients achieving normal blood pressure	14 weeks
Change from baseline in trough seated SBP	14 weeks
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 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 SBP control	14 weeks
Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.	week 8 and 14
Change from baseline in trough seated DBP	14 weeks
Change from baseline in DBP 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
Proportion of patients achieving high-normal blood pressure	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

Trial Locations

Locations (25)

Hämeenlinnan lääkäriasema Oy, Linnan klinikka; 🇫🇮 Hämeenlinna, Finland

Kouvolan lääkäriasema; 🇫🇮 Kouvola, Finland

Hatanpään terveyskeskussairaala; 🇫🇮 Tampere, Finland

Hôpital de la Timone; 🇫🇷 Marseille cedex 05, France

Deutsche Klinik für Diagnostik GmbH; 🇩🇪 Wiesbaden, Germany

Evangelisches Krankenhaus; 🇩🇪 Witten, Germany

Boehringer Ingelheim Investigational Site; 🇿🇦 Pretoria, South Africa

Diacor; 🇫🇮 Helsinki, Finland

Kiljava Medical Research; 🇫🇮 Hyvinkää, Finland

19 Redwood View; 🇮🇪 Dublin, Ireland

Adelaide and Meath Hospitals (incorrporating NCH); 🇮🇪 Dublin, Ireland

Cardioperfect Research Room; 🇮🇪 Dublin, Ireland

Ospedale S. Luigi - S. Currò; 🇮🇹 Catania, Italy

Azienda Ospedaliera "Maggiore della Carità"; 🇮🇹 Novara, Italy

Ospedale Scillesi d'America; 🇮🇹 Scilla (rc), Italy

Ospedale Civile; 🇮🇹 Vittorio Veneto (TV), Italy

C.H.U. Liège (Ourthe-Amblève); 🇧🇪 Esneux, Belgium

A.C.Z. Antwerpen/Stuyvenberg; 🇧🇪 Antwerpen, Belgium

A.Z. VUB; 🇧🇪 Brussels, Belgium

Cardiology Service; 🇪🇸 Santander, Spain

Hospital Gral de Jerez de la Frontera; 🇪🇸 Jerez de la Frontera / Cádiz, Spain

Università di Ferrara; 🇮🇹 Ferrara, Italy

Az. Osped. Universitaria "Osp. Riuniti"; 🇮🇹 Foggia, Italy

Avda. Menendez Pidal, s&n; 🇪🇸 Cordoba, Spain

Beaumont Park Clinic; 🇮🇪 Dublin, Ireland