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

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240474
• Other study ID #: 502.400
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: October 31, 2013
• Start date: December 2002
• Est. completion date: March 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Directorate General for Medicinal ProductsDenmark: Laegemiddelstyrelsen Clinical StudiesFinland: Lääkelaitos, National Agency for MedicinesFrance: French Medicine Agency (AFSSAPS)Germany: Bundesministerium für Arzneimittel und MedizinprodukteIreland: Irish Medicines BoardItaly: Comitato Etico dell'Azienda Ospedaliera "Arcispedale Sant'Anna" - Università di FerraraNetherlands: No regulatory agency approval needed for clinical trialsSouth Africa: Medicines Control CouncilSpain: Agencia Española del Medicamento
• Study type: Interventional

Clinical 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 monitoring: ABPM) in elderly patients with predominantly systolic hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan 80 mg + hydrochlorothiazide 12.5 mg

• Amlodipine 10 mg + hydrochlorothiazide 12.5 mg

Locations

Country	Name	City	State
Belgium	A.C.Z. Antwerpen/Stuyvenberg	Antwerpen
Belgium	Boehringer Ingelheim Investigational Site	Aywaille
Belgium	A.Z. VUB	Brussels
Belgium	C.H.U. Liège (Ourthe-Amblève)	Esneux
Denmark	Boehringer Ingelheim Investigational Site	Åbenrå
Denmark	Boehringer Ingelheim Investigational Site	Christianfeld
Denmark	Boehringer Ingelheim Investigational Site	Haderslev
Denmark	Boehringer Ingelheim Investigational Site	Herning
Denmark	Boehringer Ingelheim Investigational Site	Hvidovre
Denmark	Boehringer Ingelheim Investigational Site	Odder
Denmark	Boehringer Ingelheim Investigational Site	Rødovre
Denmark	Boehringer Ingelheim Investigational Site	Vildberg
Denmark	Boehringer Ingelheim Investigational Site	Vildbjerg
Denmark	Boehringer Ingelheim Investigational Site	Vinderup
Finland	Hämeenlinnan lääkäriasema Oy, Linnan klinikka	Hämeenlinna
Finland	Diacor	Helsinki
Finland	Kiljava Medical Research	Hyvinkää
Finland	Boehringer Ingelheim Investigational Site	Jyväskylä
Finland	Kouvolan lääkäriasema	Kouvola
Finland	Hatanpään terveyskeskussairaala	Tampere
France	Boehringer Ingelheim Investigational Site	Angers
France	Boehringer Ingelheim Investigational Site	Ay
France	Boehringer Ingelheim Investigational Site	Château Gontier Bazougues
France	Boehringer Ingelheim Investigational Site	Jarny
France	Hôpital de la Timone	Marseille cedex 05
France	Boehringer Ingelheim Investigational Site	Mayenne
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Berlin
Germany	Boehringer Ingelheim Investigational Site	Ellefeld
Germany	Boehringer Ingelheim Investigational Site	Esslingen
Germany	Boehringer Ingelheim Investigational Site	Flörsheim
Germany	Boehringer Ingelheim Investigational Site	Hagen
Germany	Boehringer Ingelheim Investigational Site	Hatten
Germany	Boehringer Ingelheim Investigational Site	Kelkheim
Germany	Boehringer Ingelheim Investigational Site	Leipzig
Germany	Boehringer Ingelheim Investigational Site	Marl
Germany	Boehringer Ingelheim Investigational Site	Münster
Germany	Boehringer Ingelheim Investigational Site	Nürnberg
Germany	Boehringer Ingelheim Investigational Site	Ornbau
Germany	Boehringer Ingelheim Investigational Site	Rednitzhembach
Germany	Boehringer Ingelheim Investigational Site	Riesa
Germany	Boehringer Ingelheim Investigational Site	Rodgau-Dudenhofen
Germany	Boehringer Ingelheim Investigational Site	Straßkirchen
Germany	Boehringer Ingelheim Investigational Site	Wallerfing
Germany	Boehringer Ingelheim Investigational Site	Werne
Germany	Boehringer Ingelheim Investigational Site	Westerkappeln
Germany	Deutsche Klinik für Diagnostik GmbH	Wiesbaden
Germany	Evangelisches Krankenhaus	Witten
Ireland	19 Redwood View	Dublin
Ireland	Adelaide and Meath Hospitals (incorrporating NCH)	Dublin
Ireland	Beaumont Park Clinic	Dublin
Ireland	Boehringer Ingelheim Investigational Site	Dublin
Ireland	Cardioperfect Research Room	Dublin
Ireland	Boehringer Ingelheim Investigational Site	Kilkenny
Italy	Ospedale S. Luigi - S. Currò	Catania
Italy	Università di Ferrara	Ferrara
Italy	Az. Osped. Universitaria "Osp. Riuniti"	Foggia
Italy	Azienda Ospedaliera "Maggiore della Carità"	Novara
Italy	Ospedale Scillesi d'America	Scilla (rc)
Italy	Ospedale Civile	Vittorio Veneto (TV)
Netherlands	Boehringer Ingelheim Investigational Site	Beek en Donk
Netherlands	Boehringer Ingelheim Investigational Site	Den Haag
Netherlands	Boehringer Ingelheim Investigational Site	Ewijk
Netherlands	Boehringer Ingelheim Investigational Site	Musselkanaal
Netherlands	Boehringer Ingelheim Investigational Site	Oude Pekela
Netherlands	Boehringer Ingelheim Investigational Site	Rijswijk
Netherlands	Boehringer Ingelheim Investigational Site	Roelofarendsveen
Netherlands	Boehringer Ingelheim Investigational Site	Vaals
Netherlands	Boehringer Ingelheim Investigational Site	Voerendaal
South Africa	Boehringer Ingelheim Investigational Site	Pretoria
Spain	Avda. Menendez Pidal, s&n	Cordoba
Spain	Hospital Gral de Jerez de la Frontera	Jerez de la Frontera / Cádiz
Spain	Cardiology Service	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Ireland,  Italy,  Netherlands,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		14 weeks	No
Secondary	Change from baseline in DBP in the last six hours of the 24-hour dose period		week 8 and 14	No
Secondary	Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period		week 8 and 14	No
Secondary	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))		week 8 and 14	No
Secondary	Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.		week 8 and 14	No
Secondary	Change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM).		8 weeks	No
Secondary	Proportion of patients achieving a target response in SBP		14 weeks	No
Secondary	Proportion of patients achieving SBP control		14 weeks	No
Secondary	Proportion of patients achieving normal blood pressure		14 weeks	No
Secondary	Proportion of patients achieving high-normal blood pressure		14 weeks	No
Secondary	Change from baseline in trough seated SBP		14 weeks	No
Secondary	Change from baseline in trough seated DBP		14 weeks	No
Secondary	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		14 weeks	No

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