A Comparison of Telmisartan + Hydrochlorothiazide With Amlodipine + Hydrochlorothiazide in the Control of Blood Pressure in Older Patients With Predominantly Systolic Hypertension (ATHOS Study)
NCT ID: NCT00240474
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1000 participants
INTERVENTIONAL
2002-12-31
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BIL UK / Ireland
Locations
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A.C.Z. Antwerpen/Stuyvenberg
Antwerp, , Belgium
Boehringer Ingelheim Investigational Site
Aywaille, , Belgium
A.Z. VUB
Brussels, , Belgium
C.H.U. Liège (Ourthe-Amblève)
Esneux, , Belgium
Boehringer Ingelheim Investigational Site
Aabenraa, , Denmark
Boehringer Ingelheim Investigational Site
Christiansfeld, , Denmark
Boehringer Ingelheim Investigational Site
Haderslev, , Denmark
Boehringer Ingelheim Investigational Site
Herning, , Denmark
Boehringer Ingelheim Investigational Site
Hvidovre, , Denmark
Boehringer Ingelheim Investigational Site
Odder, , Denmark
Boehringer Ingelheim Investigational Site
Rødovre Municipality, , Denmark
Boehringer Ingelheim Investigational Site
Vildberg, , Denmark
Boehringer Ingelheim Investigational Site
Vildbjerg, , Denmark
Boehringer Ingelheim Investigational Site
Vinderup, , Denmark
Hämeenlinnan lääkäriasema Oy, Linnan klinikka
Hämeenlinna, , Finland
Diacor
Helsinki, , Finland
Kiljava Medical Research
Hyvinkää, , Finland
Boehringer Ingelheim Investigational Site
Jyväskylä, , Finland
Kouvolan lääkäriasema
Kouvola, , Finland
Hatanpään terveyskeskussairaala
Tampere, , Finland
Boehringer Ingelheim Investigational Site
Angers, , France
Boehringer Ingelheim Investigational Site
Aÿ, , France
Boehringer Ingelheim Investigational Site
Château Gontier Bazougues, , France
Boehringer Ingelheim Investigational Site
Jarny, , France
Hôpital de la Timone
Marseille, , France
Boehringer Ingelheim Investigational Site
Mayenne, , France
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Berlin, , Germany
Boehringer Ingelheim Investigational Site
Ellefeld, , Germany
Boehringer Ingelheim Investigational Site
Esslingen am Neckar, , Germany
Boehringer Ingelheim Investigational Site
Flörsheim, , Germany
Boehringer Ingelheim Investigational Site
Hagen, , Germany
Boehringer Ingelheim Investigational Site
Hatten, , Germany
Boehringer Ingelheim Investigational Site
Kelkheim, , Germany
Boehringer Ingelheim Investigational Site
Leipzig, , Germany
Boehringer Ingelheim Investigational Site
Marl, , Germany
Boehringer Ingelheim Investigational Site
Münster, , Germany
Boehringer Ingelheim Investigational Site
Nuremberg, , Germany
Boehringer Ingelheim Investigational Site
Ornbau, , Germany
Boehringer Ingelheim Investigational Site
Rednitzhembach, , Germany
Boehringer Ingelheim Investigational Site
Riesa, , Germany
Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen, , Germany
Boehringer Ingelheim Investigational Site
Straßkirchen, , Germany
Boehringer Ingelheim Investigational Site
Wallerfing, , Germany
Boehringer Ingelheim Investigational Site
Werne, , Germany
Boehringer Ingelheim Investigational Site
Westerkappeln, , Germany
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, , Germany
Evangelisches Krankenhaus
Witten, , Germany
19 Redwood View
Dublin, , Ireland
Adelaide and Meath Hospitals (incorrporating NCH)
Dublin, , Ireland
Boehringer Ingelheim Investigational Site
Dublin, , Ireland
Cardioperfect Research Room
Dublin, , Ireland
Beaumont Park Clinic
Dublin, , Ireland
Boehringer Ingelheim Investigational Site
Kilkenny, , Ireland
Ospedale S. Luigi - S. Currò
Catania, , Italy
Università di Ferrara
Ferrara, , Italy
Az. Osped. Universitaria "Osp. Riuniti"
Foggia, , Italy
Azienda Ospedaliera "Maggiore della Carità"
Novara, , Italy
Ospedale Scillesi d'America
Scilla (rc), , Italy
Ospedale Civile
Vittorio Veneto (TV), , Italy
Boehringer Ingelheim Investigational Site
Beek en Donk, , Netherlands
Boehringer Ingelheim Investigational Site
Ewijk, , Netherlands
Boehringer Ingelheim Investigational Site
Musselkanaal, , Netherlands
Boehringer Ingelheim Investigational Site
Oude Pekela, , Netherlands
Boehringer Ingelheim Investigational Site
Rijswijk, , Netherlands
Boehringer Ingelheim Investigational Site
Roelofarendsveen, , Netherlands
Boehringer Ingelheim Investigational Site
The Hague, , Netherlands
Boehringer Ingelheim Investigational Site
Vaals, , Netherlands
Boehringer Ingelheim Investigational Site
Voerendaal, , Netherlands
Boehringer Ingelheim Investigational Site
Pretoria, , South Africa
Avda. Menendez Pidal, s&n
Córdoba, , Spain
Hospital Gral de Jerez de la Frontera
Jerez de La Frontera / Cádiz, , Spain
Cardiology Service
Santander, , Spain
Countries
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Other Identifiers
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502.400
Identifier Type: -
Identifier Source: org_study_id