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

October 31, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
        • A.C.Z. Antwerpen/Stuyvenberg
      • Aywaille, Belgium, 4920
        • Boehringer Ingelheim Investigational Site
      • Brussels, Belgium, 1090
        • A.Z. VUB
      • Esneux, Belgium, 4130
        • C.H.U. Liège (Ourthe-Amblève)
  • Denmark
      • 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
        • Boehringer Ingelheim Investigational Site
  • Finland
      • Helsinki, Finland, FIN-00530
        • Diacor
      • Hyvinkää, Finland, FIN-05800
        • Kiljava Medical Research
      • Hämeenlinna, Finland, FIN-13100
        • Hämeenlinnan lääkäriasema Oy, Linnan klinikka
      • Jyväskylä, Finland, FIN-40100
        • Boehringer Ingelheim Investigational Site
      • Kouvola, Finland, FIN-45100
        • Kouvolan lääkäriasema
      • Tampere, Finland, FIN-33100
        • Hatanpään terveyskeskussairaala
  • France
      • Angers, France
        • Boehringer Ingelheim Investigational Site
      • Ay, France
        • Boehringer Ingelheim Investigational Site
      • Château Gontier Bazougues, France, 53200
        • Boehringer Ingelheim Investigational Site
      • Jarny, France, 54800
        • Boehringer Ingelheim Investigational Site
      • Marseille cedex 05, France, 13385
        • Hôpital de la Timone
      • Mayenne, France, 53100
        • Boehringer Ingelheim Investigational Site
  • Germany
      • 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
        • Boehringer Ingelheim Investigational Site
      • Wiesbaden, Germany, 65191
        • Deutsche Klinik für Diagnostik GmbH
      • Witten, Germany, 58455
        • Evangelisches Krankenhaus
  • Ireland
      • Dublin, Ireland, 24
        • 19 Redwood View
      • Dublin, Ireland, 24
        • Adelaide and Meath Hospitals (incorrporating NCH)
      • Dublin, Ireland, 7
        • Boehringer Ingelheim Investigational Site
      • Dublin, Ireland, 8
        • Cardioperfect Research Room
      • Dublin, Ireland, 9
        • Beaumont Park Clinic
      • Kilkenny, Ireland
        • Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy, 95100
        • Ospedale S. Luigi - S. Currò
      • Ferrara, Italy, 44100
        • Università di Ferrara
      • Foggia, Italy
        • Az. Osped. Universitaria "Osp. Riuniti"
      • Novara, Italy, 28100
        • Azienda Ospedaliera "Maggiore della Carità"
      • Scilla (rc), Italy, 89058
        • Ospedale Scillesi D'America
      • Vittorio Veneto (TV), Italy, 31029
        • Ospedale Civile
  • Netherlands
      • 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
        • Boehringer Ingelheim Investigational Site
  • South Africa
      • Pretoria, South Africa, 0038
        • Boehringer Ingelheim Investigational Site
  • Spain
      • Cordoba, Spain, 14004
        • Avda. Menendez Pidal, s&n
      • Jerez de la Frontera / Cádiz, Spain, 11407
        • Hospital Gral de Jerez de la Frontera
      • Santander, Spain, 39008
        • Cardiology Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in DBP in the last six hours of the 24-hour dose period
Time Frame: week 8 and 14
week 8 and 14
Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period
Time Frame: week 8 and 14
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))
Time Frame: week 8 and 14
week 8 and 14
Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.
Time Frame: week 8 and 14
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).
Time Frame: 8 weeks
8 weeks
Proportion of patients achieving a target response in SBP
Time Frame: 14 weeks
14 weeks
Proportion of patients achieving SBP control
Time Frame: 14 weeks
14 weeks
Proportion of patients achieving normal blood pressure
Time Frame: 14 weeks
14 weeks
Proportion of patients achieving high-normal blood pressure
Time Frame: 14 weeks
14 weeks
Change from baseline in trough seated SBP
Time Frame: 14 weeks
14 weeks
Change from baseline in trough seated DBP
Time Frame: 14 weeks
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
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (ACTUAL)

March 1, 2004

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (ESTIMATE)

October 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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