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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00240474
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg
Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in DBP in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • 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)) [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index. [ Time Frame: week 8 and 14 ] [ Designated as safety issue: No ]
  • Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a target response in SBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving SBP control [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving normal blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving high-normal blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in trough seated SBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in trough seated DBP [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: December 2002
Estimated Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240474

  Hide Study Locations
Locations
Belgium
A.C.Z. Antwerpen/Stuyvenberg
Antwerpen, Belgium, 2060
Boehringer Ingelheim Investigational Site
Aywaille, Belgium, 4920
A.Z. VUB
Brussels, Belgium, 1090
C.H.U. Liège (Ourthe-Amblève)
Esneux, Belgium, 4130
Denmark
Boehringer Ingelheim Investigational Site
Christianfeld, Denmark, DK-6070
Boehringer Ingelheim Investigational Site
Haderslev, Denmark, DK-6100
Boehringer Ingelheim Investigational Site
Herning, Denmark, DK-7400
Boehringer Ingelheim Investigational Site
Hvidovre, Denmark, DK-2650
Boehringer Ingelheim Investigational Site
Odder, Denmark, 8300
Boehringer Ingelheim Investigational Site
Rødovre, Denmark, DK-2610
Boehringer Ingelheim Investigational Site
Vildberg, Denmark, DK-7480
Boehringer Ingelheim Investigational Site
Vildbjerg, Denmark, DK-7480
Boehringer Ingelheim Investigational Site
Vinderup, Denmark, DK-7830
Boehringer Ingelheim Investigational Site
Åbenrå, Denmark, DK-6200
Finland
Diacor
Helsinki, Finland, FIN-00530
Kiljava Medical Research
Hyvinkää, Finland, FIN-05800
Hämeenlinnan lääkäriasema Oy, Linnan klinikka
Hämeenlinna, Finland, FIN-13100
Boehringer Ingelheim Investigational Site
Jyväskylä, Finland, FIN-40100
Kouvolan lääkäriasema
Kouvola, Finland, FIN-45100
Hatanpään terveyskeskussairaala
Tampere, Finland, FIN-33100
France
Boehringer Ingelheim Investigational Site
Angers, France
Boehringer Ingelheim Investigational Site
Ay, France
Boehringer Ingelheim Investigational Site
Château Gontier Bazougues, France, 53200
Boehringer Ingelheim Investigational Site
Jarny, France, 54800
Hôpital de la Timone
Marseille cedex 05, France, 13385
Boehringer Ingelheim Investigational Site
Mayenne, France, 53100
Germany
Boehringer Ingelheim Investigational Site
Berlin, Germany, 12459
Boehringer Ingelheim Investigational Site
Berlin, Germany, 13051
Boehringer Ingelheim Investigational Site
Ellefeld, Germany, 08236
Boehringer Ingelheim Investigational Site
Esslingen, Germany, 73733
Boehringer Ingelheim Investigational Site
Flörsheim, Germany, 65439
Boehringer Ingelheim Investigational Site
Hagen, Germany, 58091
Boehringer Ingelheim Investigational Site
Hatten, Germany, 26209
Boehringer Ingelheim Investigational Site
Kelkheim, Germany, 65779
Boehringer Ingelheim Investigational Site
Leipzig, Germany, 04329
Boehringer Ingelheim Investigational Site
Marl, Germany, 45772
Boehringer Ingelheim Investigational Site
Münster, Germany, 48155
Boehringer Ingelheim Investigational Site
Nürnberg, Germany, 90402
Boehringer Ingelheim Investigational Site
Ornbau, Germany, 91737
Boehringer Ingelheim Investigational Site
Rednitzhembach, Germany, 91126
Boehringer Ingelheim Investigational Site
Riesa, Germany, 01589
Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen, Germany, 63110
Boehringer Ingelheim Investigational Site
Straßkirchen, Germany, 94342
Boehringer Ingelheim Investigational Site
Wallerfing, Germany, 94574
Boehringer Ingelheim Investigational Site
Werne, Germany, 59368
Boehringer Ingelheim Investigational Site
Westerkappeln, Germany, 49492
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, Germany, 65191
Evangelisches Krankenhaus
Witten, Germany, 58455
Ireland
Beaumont Park Clinic
Dublin, Ireland, 9
Cardioperfect Research Room
Dublin, Ireland, 8
Boehringer Ingelheim Investigational Site
Dublin, Ireland, 7
Adelaide and Meath Hospitals (incorrporating NCH)
Dublin, Ireland, 24
19 Redwood View
Dublin, Ireland, 24
Boehringer Ingelheim Investigational Site
Kilkenny, Ireland
Italy
Ospedale S. Luigi - S. Currò
Catania, Italy, 95100
Università di Ferrara
Ferrara, Italy, 44100
Az. Osped. Universitaria "Osp. Riuniti"
Foggia, Italy
Azienda Ospedaliera "Maggiore della Carità"
Novara, Italy, 28100
Ospedale Scillesi d'America
Scilla (rc), Italy, 89058
Ospedale Civile
Vittorio Veneto (TV), Italy, 31029
Netherlands
Boehringer Ingelheim Investigational Site
Beek en Donk, Netherlands, 5741 AR
Boehringer Ingelheim Investigational Site
Den Haag, Netherlands, 2585 LJ
Boehringer Ingelheim Investigational Site
Ewijk, Netherlands, 6644 CL
Boehringer Ingelheim Investigational Site
Musselkanaal, Netherlands
Boehringer Ingelheim Investigational Site
Oude Pekela, Netherlands, 9665 AR
Boehringer Ingelheim Investigational Site
Rijswijk, Netherlands, 2281 AK
Boehringer Ingelheim Investigational Site
Roelofarendsveen, Netherlands, 2371 RB
Boehringer Ingelheim Investigational Site
Vaals, Netherlands
Boehringer Ingelheim Investigational Site
Voerendaal, Netherlands
South Africa
Boehringer Ingelheim Investigational Site
Pretoria, South Africa, 0038
Spain
Avda. Menendez Pidal, s&n
Cordoba, Spain, 14004
Hospital Gral de Jerez de la Frontera
Jerez de la Frontera / Cádiz, Spain, 11407
Cardiology Service
Santander, Spain, 39008
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00240474     History of Changes
Other Study ID Numbers: 502.400
Study First Received: October 14, 2005
Last Updated: October 31, 2013
Health Authority: Belgium: Directorate General for Medicinal Products
Denmark: Laegemiddelstyrelsen Clinical Studies
Finland: Lääkelaitos, National Agency for Medicines
France: French Medicine Agency (AFSSAPS)
Germany: Bundesministerium für Arzneimittel und Medizinprodukte
Ireland: Irish Medicines Board
Italy: Comitato Etico dell'Azienda Ospedaliera "Arcispedale Sant'Anna" - Università di Ferrara
Netherlands: No regulatory agency approval needed for clinical trials
South Africa: Medicines Control Council
Spain: Agencia Española del Medicamento

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Telmisartan
Telmisartan, hydrochlorothiazide drug combination
Benzoates
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 21, 2014