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

NCT00240474 | Completed Phase 4

• 1 other identifier: 502.400
• Study Type: interventional
• Target: 1,000
• Locations: 10 countries
• Sites: 73

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Change from baseline in DBP in the last six hours of the 24-hour dose period

  week 8 and 14

• Change from baseline in pulse pressure (PP) in the last six hours of the 24-hour dose period

  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))

  week 8 and 14

• Change from baseline in patient HRQL as measured by the Psychological General Well-Being (PGWB) index.

  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).

  8 weeks

Interventions

Telmisartan 80 mg + hydrochlorothiazide 12.5 mg DRUG

Amlodipine 10 mg + hydrochlorothiazide 12.5 mg DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged at least 60 years old
• mean SBP greater than 140 mmHg and mean DBP less than or equal to 95 mmHg
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (73)

A.C.Z. Antwerpen/Stuyvenberg

Antwerp, 2060, Belgium

Location

Boehringer Ingelheim Investigational Site

Aywaille, 4920, Belgium

Location

A.Z. VUB

Brussels, 1090, Belgium

Location

C.H.U. Liège (Ourthe-Amblève)

Esneux, 4130, Belgium

Location

Boehringer Ingelheim Investigational Site

Aabenraa, DK-6200, Denmark

Location

Boehringer Ingelheim Investigational Site

Christiansfeld, DK-6070, Denmark

Location

Boehringer Ingelheim Investigational Site

Haderslev, DK-6100, Denmark

Location

Boehringer Ingelheim Investigational Site

Herning, DK-7400, Denmark

Location

Boehringer Ingelheim Investigational Site

Hvidovre, DK-2650, Denmark

Location

Boehringer Ingelheim Investigational Site

Odder, 8300, Denmark

Location

Boehringer Ingelheim Investigational Site

Rødovre Municipality, DK-2610, Denmark

Location

Boehringer Ingelheim Investigational Site

Vildberg, DK-7480, Denmark

Location

Boehringer Ingelheim Investigational Site

Vildbjerg, DK-7480, Denmark

Location

Boehringer Ingelheim Investigational Site

Vinderup, DK-7830, Denmark

Location

Hämeenlinnan lääkäriasema Oy, Linnan klinikka

Hämeenlinna, FIN-13100, Finland

Location

Diacor

Helsinki, FIN-00530, Finland

Location

Kiljava Medical Research

Hyvinkää, FIN-05800, Finland

Location

Boehringer Ingelheim Investigational Site

Jyväskylä, FIN-40100, Finland

Location

Kouvolan lääkäriasema

Kouvola, FIN-45100, Finland

Location

Hatanpään terveyskeskussairaala

Tampere, FIN-33100, Finland

Location

Boehringer Ingelheim Investigational Site

Angers, France

Location

Boehringer Ingelheim Investigational Site

Aÿ, France

Location

Boehringer Ingelheim Investigational Site

Château Gontier Bazougues, 53200, France

Location

Boehringer Ingelheim Investigational Site

Jarny, 54800, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

Boehringer Ingelheim Investigational Site

Mayenne, 53100, France

Location

Boehringer Ingelheim Investigational Site

Berlin, 12459, Germany

Location

Boehringer Ingelheim Investigational Site

Berlin, 13051, Germany

Location

Boehringer Ingelheim Investigational Site

Ellefeld, 08236, Germany

Location

Boehringer Ingelheim Investigational Site

Esslingen am Neckar, 73733, Germany

Location

Boehringer Ingelheim Investigational Site

Flörsheim, 65439, Germany

Location

Boehringer Ingelheim Investigational Site

Hagen, 58091, Germany

Location

Boehringer Ingelheim Investigational Site

Hatten, 26209, Germany

Location

Boehringer Ingelheim Investigational Site

Kelkheim, 65779, Germany

Location

Boehringer Ingelheim Investigational Site

Leipzig, 04329, Germany

Location

Boehringer Ingelheim Investigational Site

Marl, 45772, Germany

Location

Boehringer Ingelheim Investigational Site

Münster, 48155, Germany

Location

Boehringer Ingelheim Investigational Site

Nuremberg, 90402, Germany

Location

Boehringer Ingelheim Investigational Site

Ornbau, 91737, Germany

Location

Boehringer Ingelheim Investigational Site

Rednitzhembach, 91126, Germany

Location

Boehringer Ingelheim Investigational Site

Riesa, 01589, Germany

Location

Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, 63110, Germany

Location

Boehringer Ingelheim Investigational Site

Straßkirchen, 94342, Germany

Location

Boehringer Ingelheim Investigational Site

Wallerfing, 94574, Germany

Location

Boehringer Ingelheim Investigational Site

Werne, 59368, Germany

Location

Boehringer Ingelheim Investigational Site

Westerkappeln, 49492, Germany

Location

Deutsche Klinik für Diagnostik GmbH

Wiesbaden, 65191, Germany

Location

Evangelisches Krankenhaus

Witten, 58455, Germany

Location

19 Redwood View

Dublin, 24, Ireland

Location

Adelaide and Meath Hospitals (incorrporating NCH)

Dublin, 24, Ireland

Location

Boehringer Ingelheim Investigational Site

Dublin, 7, Ireland

Location

Cardioperfect Research Room

Dublin, 8, Ireland

Location

Beaumont Park Clinic

Dublin, 9, Ireland

Location

Boehringer Ingelheim Investigational Site

Kilkenny, Ireland

Location

Ospedale S. Luigi - S. Currò

Catania, 95100, Italy

Location

Università di Ferrara

Ferrara, 44100, Italy

Location

Az. Osped. Universitaria "Osp. Riuniti"

Foggia, Italy

Location

Azienda Ospedaliera "Maggiore della Carità"

Novara, 28100, Italy

Location

Ospedale Scillesi d'America

Scilla (rc), 89058, Italy

Location

Ospedale Civile

Vittorio Veneto (TV), 31029, Italy

Location

Boehringer Ingelheim Investigational Site

Beek en Donk, 5741 AR, Netherlands

Location

Boehringer Ingelheim Investigational Site

Ewijk, 6644 CL, Netherlands

Location

Boehringer Ingelheim Investigational Site

Musselkanaal, Netherlands

Location

Boehringer Ingelheim Investigational Site

Oude Pekela, 9665 AR, Netherlands

Location

Boehringer Ingelheim Investigational Site

Rijswijk, 2281 AK, Netherlands

Location

Boehringer Ingelheim Investigational Site

Roelofarendsveen, 2371 RB, Netherlands

Location

Boehringer Ingelheim Investigational Site

The Hague, 2585 LJ, Netherlands

Location

Boehringer Ingelheim Investigational Site

Vaals, Netherlands

Location

Boehringer Ingelheim Investigational Site

Voerendaal, Netherlands

Location

Boehringer Ingelheim Investigational Site

Pretoria, 0038, South Africa

Location

Avda. Menendez Pidal, s&n

Córdoba, 14004, Spain

Location

Hospital Gral de Jerez de la Frontera

Jerez de La Frontera / Cádiz, 11407, Spain

Location

Cardiology Service

Santander, 39008, Spain

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  BIL UK / Ireland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: December 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DK (10); BE (4); NL (9); FR (6); DE (22); ZA (1); FI (6); ES (3); IE (6); IT (6)