Clinical trial NCT00240474: A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 14 weeks
Secondary outcomes:
measure: Change from baseline in DBP in the last six hours of the 24-hour dose period
timeFrame: week 8 and 14
measure: Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period
timeFrame: week 8 and 14
measure: 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))
timeFrame: week 8 and 14
measure: Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.
timeFrame: week 8 and 14
measure: Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).
timeFrame: 8 weeks
measure: Proportion of patients achieving a target response in SBP
timeFrame: 14 weeks
measure: Proportion of patients achieving SBP control
timeFrame: 14 weeks
measure: Proportion of patients achieving normal blood pressure
timeFrame: 14 weeks
measure: Proportion of patients achieving high-normal blood pressure
timeFrame: 14 weeks
measure: Change from baseline in trough seated SBP
timeFrame: 14 weeks
measure: Change from baseline in trough seated DBP
timeFrame: 14 weeks
measure: 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
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: A.C.Z. Antwerpen/Stuyvenberg
city: Aywaille
country: Belgium
facility: Boehringer Ingelheim Investigational Site
city: Brussels
country: Belgium
facility: A.Z. VUB
city: Esneux
country: Belgium
facility: C.H.U. Liège (Ourthe-Amblève)
city: Christianfeld
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Haderslev
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Herning
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Odder
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Rødovre
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Vildberg
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Vildbjerg
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Vinderup
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Åbenrå
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: Diacor
city: Hyvinkää
country: Finland
facility: Kiljava Medical Research
city: Hämeenlinna
country: Finland
facility: Hämeenlinnan lääkäriasema Oy, Linnan klinikka
city: Jyväskylä
country: Finland
facility: Boehringer Ingelheim Investigational Site
city: Kouvola
country: Finland
facility: Kouvolan lääkäriasema
city: Tampere
country: Finland
facility: Hatanpään terveyskeskussairaala
city: Angers
country: France
facility: Boehringer Ingelheim Investigational Site
city: Ay
country: France
facility: Boehringer Ingelheim Investigational Site
city: Château Gontier Bazougues
country: France
facility: Boehringer Ingelheim Investigational Site
city: Jarny
country: France
facility: Boehringer Ingelheim Investigational Site
city: Marseille cedex 05
country: France
facility: Hôpital de la Timone
city: Mayenne
country: France
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ellefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Esslingen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Flörsheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hagen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Hatten
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Kelkheim
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Marl
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Ornbau
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rednitzhembach
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Riesa
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rodgau-Dudenhofen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Straßkirchen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wallerfing
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Werne
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Westerkappeln
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik GmbH
city: Witten
country: Germany
facility: Evangelisches Krankenhaus
city: Dublin
country: Ireland
facility: 19 Redwood View
city: Dublin
country: Ireland
facility: Adelaide and Meath Hospitals (incorrporating NCH)
city: Dublin
country: Ireland
facility: Boehringer Ingelheim Investigational Site
city: Dublin
country: Ireland
facility: Cardioperfect Research Room
city: Dublin
country: Ireland
facility: Beaumont Park Clinic
city: Kilkenny
country: Ireland
facility: Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: Ospedale S. Luigi - S. Currò
city: Ferrara
country: Italy
facility: Università di Ferrara
city: Foggia
country: Italy
facility: Az. Osped. Universitaria "Osp. Riuniti"
city: Novara
country: Italy
facility: Azienda Ospedaliera "Maggiore della Carità"
city: Scilla (rc)
country: Italy
facility: Ospedale Scillesi d'America
city: Vittorio Veneto (TV)
country: Italy
facility: Ospedale Civile
city: Beek en Donk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Ewijk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Musselkanaal
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Rijswijk
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Roelofarendsveen
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Vaals
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Voerendaal
country: Netherlands
facility: Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: Boehringer Ingelheim Investigational Site
city: Cordoba
country: Spain
facility: Avda. Menendez Pidal, s&n
city: Jerez de la Frontera / Cádiz
country: Spain
facility: Hospital Gral de Jerez de la Frontera
city: Santander
country: Spain
facility: Cardiology Service
Study officials:
affiliation: BIL UK / Ireland
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: