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

Condition(s) targeted: Hypertension

Intervention: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg (Drug); Amlodipine 10 mg + hydrochlorothiazide 12.5 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: BIL UK / Ireland

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- aged at least 60 years of age

- 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

C.H.U. Liège (Ourthe-Amblève), Esneux 4130, Belgium

Boehringer Ingelheim Investigational Site, Aywaille 4920, Belgium

a.Z. VUB, Brussels 1090, Belgium

A.C.Z. Antwerpen/Stuyvenberg, Antwerpen 2060, Belgium

Boehringer Ingelheim Investigational Site, Rødovre DK-2610, Denmark

Boehringer Ingelheim Investigational Site, Vildbjerg DK-7480, Denmark

Boehringer Ingelheim Investigational Site, Herning DK-7400, Denmark

Boehringer Ingelheim Investigational Site, Haderslev DK-6100, Denmark

Boehringer Ingelheim Investigational Site, Vinderup DK-7830, Denmark

Boehringer Ingelheim Investigational Site, Christianfeld DK-6070, Denmark

Boehringer Ingelheim Investigational Site, Vildberg DK-7480, Denmark

Boehringer Ingelheim Investigational Site, Åbenrå DK-6200, Denmark

Boehringer Ingelheim Investigational Site, Hvidovre DK-2650, Denmark

Boehringer Ingelheim Investigational Site, Odder 8300, Denmark

Kiljava Medical Research, Hyvinkää FIN-05800, Finland

Kouvolan lääkäriasema, Kouvola FIN-45100, Finland

Hatanpään terveyskeskussairaala, Tampere FIN-33100, Finland

Diacor, Helsinki FIN-00530, Finland

Hämeenlinnan lääkäriasema Oy, Linnan klinikka, Hämeenlinna FIN-13100, Finland

Boehringer Ingelheim Investigational Site, Jyväskylä FIN-40100, Finland

Hôpital de la Timone, Marseille cedex 05 13385, France

Boehringer Ingelheim Investigational Site, Angers, France

Boehringer Ingelheim Investigational Site, Château Gontier Bazougues 53200, France

Boehringer Ingelheim Investigational Site, Mayenne 53100, France

Boehringer Ingelheim Investigational Site, Jarny 54800, France

Boehringer Ingelheim Investigational Site, Ay, France

Boehringer Ingelheim Investigational Site, Straßkirchen 94342, Germany

Boehringer Ingelheim Investigational Site, Wallerfing 94574, Germany

Boehringer Ingelheim Investigational Site, Hatten 26209, Germany

Boehringer Ingelheim Investigational Site, Leipzig 04329, Germany

Boehringer Ingelheim Investigational Site, Marl 45772, Germany

Boehringer Ingelheim Investigational Site, Esslingen 73733, Germany

Boehringer Ingelheim Investigational Site, Rednitzhembach 91126, Germany

Boehringer Ingelheim Investigational Site, Rodgau-Dudenhofen 63110, Germany

Boehringer Ingelheim Investigational Site, Berlin 12459, Germany

Boehringer Ingelheim Investigational Site, Nürnberg 90402, Germany

Boehringer Ingelheim Investigational Site, Ellefeld 08236, Germany

Boehringer Ingelheim Investigational Site, Riesa 01589, Germany

Boehringer Ingelheim Investigational Site, Hagen 58091, Germany

Evangelisches Krankenhaus, Witten 58455, Germany

Boehringer Ingelheim Investigational Site, Ornbau 91737, Germany

Boehringer Ingelheim Investigational Site, Münster 48155, Germany

Deutsche Klinik für Diagnostik GmbH, Wiesbaden 65191, Germany

Boehringer Ingelheim Investigational Site, Berlin 13051, Germany

Boehringer Ingelheim Investigational Site, Kelkheim 65779, Germany

Boehringer Ingelheim Investigational Site, Flörsheim 65439, Germany

Boehringer Ingelheim Investigational Site, Werne 59368, Germany

Boehringer Ingelheim Investigational Site, Westerkappeln 49492, Germany

Beaumont Park Clinic, Dublin 9, Ireland

Boehringer Ingelheim Investigational Site, Kilkenny, Ireland

Boehringer Ingelheim Investigational Site, Dublin 7, Ireland

Cardioperfect Research Room, Dublin 8, Ireland

Adelaide and Meath Hospitals (incorrporating NCH), Dublin 24, Ireland

19 Redwood View, Dublin 24, Ireland

Università di Ferrara, FERRARA 44100, Italy

Ospedale Civile, Vittorio Veneto (TV) 31029, Italy

Az. Osped. Universitaria "Osp. Riuniti", Foggia, Italy

Ospedale S. Luigi - S. Currò, CATANIA 95100, Italy

Ospedale Scillesi d'America, SCILLA (RC) 89058, Italy

Azienda Ospedaliera "Maggiore della Carità", NOVARA 28100, Italy

Boehringer Ingelheim Investigational Site, Rijswijk 2281 AK, Netherlands

Boehringer Ingelheim Investigational Site, Ewijk 6644 CL, Netherlands

Boehringer Ingelheim Investigational Site, Roelofarendsveen 2371 RB, Netherlands

Boehringer Ingelheim Investigational Site, Vaals, Netherlands

Boehringer Ingelheim Investigational Site, Beek en Donk 5741 AR, Netherlands

Boehringer Ingelheim Investigational Site, Voerendaal, Netherlands

Boehringer Ingelheim Investigational Site, Oude Pekela 9665 AR, Netherlands

Boehringer Ingelheim Investigational Site, Musselkanaal, Netherlands

Boehringer Ingelheim Investigational Site, Den Haag 2585 LJ, Netherlands

Boehringer Ingelheim Investigational Site, Pretoria 0038, South Africa

Cardiology Service, Santander 39008, Spain

Hospital Gral de Jerez de la Frontera, Jerez de la Frontera / Cádiz 11407, Spain

Avda. Menendez Pidal, s&n, Cordoba 14004, Spain

Starting date: November 2002
Ending date: March 2004
Last updated: June 5, 2008