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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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