HypertensionPhase 4NCT00240474

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

A Phase 4 study testing Telmisartan 80 mg + hydrochlorothiazide 12.5 mg and Amlodipine 10 mg + hydrochlorothiazide 12.5 mg in people with Hypertension, run by Boehringer Ingelheim at 73 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Hypertension
What is being tested?: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg and Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
How many people: 1,000 participants
Where: 73 sitesin 10 countries
Study dates: Dec 2002to Mar 2004
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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

Trial locations and contacts

73 sites in 10 countries.

Country

City, postcode or hospital

73 sites in 10 countries

Germany22 sites

Boehringer Ingelheim Investigational Site
Berlin, 12459
Boehringer Ingelheim Investigational Site
Berlin, 13051
Boehringer Ingelheim Investigational Site
Ellefeld, 08236
Boehringer Ingelheim Investigational Site
Esslingen am Neckar, 73733
Boehringer Ingelheim Investigational Site
Flörsheim, 65439
Boehringer Ingelheim Investigational Site
Hagen, 58091
Boehringer Ingelheim Investigational Site
Hatten, 26209
Boehringer Ingelheim Investigational Site
Kelkheim, 65779
Boehringer Ingelheim Investigational Site
Leipzig, 04329
Boehringer Ingelheim Investigational Site
Marl, 45772
Boehringer Ingelheim Investigational Site
Münster, 48155
Boehringer Ingelheim Investigational Site
Nuremberg, 90402
Boehringer Ingelheim Investigational Site
Ornbau, 91737
Boehringer Ingelheim Investigational Site
Rednitzhembach, 91126
Boehringer Ingelheim Investigational Site
Riesa, 01589
Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen, 63110
Boehringer Ingelheim Investigational Site
Straßkirchen, 94342
Boehringer Ingelheim Investigational Site
Wallerfing, 94574
Boehringer Ingelheim Investigational Site
Werne, 59368
Boehringer Ingelheim Investigational Site
Westerkappeln, 49492
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, 65191
Evangelisches Krankenhaus
Witten, 58455

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Denmark10 sites

Boehringer Ingelheim Investigational Site
Aabenraa, DK-6200
Boehringer Ingelheim Investigational Site
Christiansfeld, DK-6070
Boehringer Ingelheim Investigational Site
Haderslev, DK-6100
Boehringer Ingelheim Investigational Site
Herning, DK-7400
Boehringer Ingelheim Investigational Site
Hvidovre, DK-2650
Boehringer Ingelheim Investigational Site
Odder, 8300
Boehringer Ingelheim Investigational Site
Rødovre Municipality, DK-2610
Boehringer Ingelheim Investigational Site
Vildberg, DK-7480
Boehringer Ingelheim Investigational Site
Vildbjerg, DK-7480
Boehringer Ingelheim Investigational Site
Vinderup, DK-7830

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Netherlands9 sites

Boehringer Ingelheim Investigational Site
Beek en Donk, 5741 AR
Boehringer Ingelheim Investigational Site
Ewijk, 6644 CL
Boehringer Ingelheim Investigational Site
Musselkanaal
Boehringer Ingelheim Investigational Site
Oude Pekela, 9665 AR
Boehringer Ingelheim Investigational Site
Rijswijk, 2281 AK
Boehringer Ingelheim Investigational Site
Roelofarendsveen, 2371 RB
Boehringer Ingelheim Investigational Site
The Hague, 2585 LJ
Boehringer Ingelheim Investigational Site
Vaals
Boehringer Ingelheim Investigational Site
Voerendaal

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Finland6 sites

Hämeenlinnan lääkäriasema Oy, Linnan klinikka
Hämeenlinna, FIN-13100
Diacor
Helsinki, FIN-00530
Kiljava Medical Research
Hyvinkää, FIN-05800
Boehringer Ingelheim Investigational Site
Jyväskylä, FIN-40100
Kouvolan lääkäriasema
Kouvola, FIN-45100
Hatanpään terveyskeskussairaala
Tampere, FIN-33100

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France6 sites

Boehringer Ingelheim Investigational Site
Angers
Boehringer Ingelheim Investigational Site
Aÿ
Boehringer Ingelheim Investigational Site
Château Gontier Bazougues, 53200
Boehringer Ingelheim Investigational Site
Jarny, 54800
Hôpital de la Timone
Marseille, 13385
Boehringer Ingelheim Investigational Site
Mayenne, 53100

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Ireland6 sites

19 Redwood View
Dublin, 24
Adelaide and Meath Hospitals (incorrporating NCH)
Dublin, 24
Boehringer Ingelheim Investigational Site
Dublin, 7
Cardioperfect Research Room
Dublin, 8
Beaumont Park Clinic
Dublin, 9
Boehringer Ingelheim Investigational Site
Kilkenny

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Italy6 sites

Ospedale S. Luigi - S. Currò
Catania, 95100
Università di Ferrara
Ferrara, 44100
Az. Osped. Universitaria "Osp. Riuniti"
Foggia
Azienda Ospedaliera "Maggiore della Carità"
Novara, 28100
Ospedale Scillesi d'America
Scilla (rc), 89058
Ospedale Civile
Vittorio Veneto (TV), 31029

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Belgium4 sites

A.C.Z. Antwerpen/Stuyvenberg
Antwerp, 2060
Boehringer Ingelheim Investigational Site
Aywaille, 4920
A.Z. VUB
Brussels, 1090
C.H.U. Liège (Ourthe-Amblève)
Esneux, 4130

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Spain3 sites

Avda. Menendez Pidal, s&n
Córdoba, 14004
Hospital Gral de Jerez de la Frontera
Jerez de La Frontera / Cádiz, 11407
Cardiology Service
Santander, 39008

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South Africa1 site

Boehringer Ingelheim Investigational Site
Pretoria, 0038

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About this study

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)

Conditions: Hypertension
Being tested: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg, Amlodipine 10 mg + hydrochlorothiazide 12.5 mg
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telmisartan 80 mg + hydrochlorothiazide 12.5 mgDrug
Amlodipine 10 mg + hydrochlorothiazide 12.5 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 14 weeks

Secondary outcomes (12)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2002Mar 2004

First posted18 Oct 2005 (estimated)
Study startDec 2002
Primary completionMar 2004
Study completionMar 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00240474
Sponsor's protocol ID: 502.400
Status last verified: Oct 2013
First submitted: 14 Oct 2005
Last updated: 1 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00240474
Acronym / sponsor ID: 502.400
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Dec 2002
Primary completion: Mar 2004 (actual)
Study completion: Mar 2004
First posted: 18 Oct 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (25 listed)

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:
primary aldosteronism

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telmisartan 80 mg + hydrochlorothiazide 12.5 mg	Drug	–
Amlodipine 10 mg + hydrochlorothiazide 12.5 mg	Drug	–

Primary outcome

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

12 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

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Chronic Kidney Disease, Hypertension (HTN)
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim Study Coordinator study chair

BIL UK / Ireland

73 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in Germany, Denmark, Netherlands, Finland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00240474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.