|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00240474 |
Purpose
The primary objective of this clinical trial was to show that the combination of telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg was not inferior to and was possibly superior to amlodipine 10 mg + HCTZ 12.5 mg in reducing the systolic blood pressure (SBP) in the last six hours of the 24-hour dose period [as measured by 24-hour ambulatory blood pressure monitoring ( ABPM)] in elderly patients with predominantly systolic hypertension. The primary endpoint was the change from baseline in SBP in the last six hours of the 24-hour dose period (as measured by 24-hour ABPM) at the end-of-study visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Telmisartan 80 mg + hydrochlorothiazide 12.5 mg Drug: Amlodipine 10 mg + hydrochlorothiazide 12.5 mg |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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) |
| Estimated Enrollment: | 850 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | March 2004 |
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contacts and Locations
Hide Study Locations| Belgium | |
| C.H.U. Liège (Ourthe-Amblève) | |
| Esneux, Belgium, 4130 | |
| Boehringer Ingelheim Investigational Site | |
| Aywaille, Belgium, 4920 | |
| a.Z. VUB | |
| Brussels, Belgium, 1090 | |
| A.C.Z. Antwerpen/Stuyvenberg | |
| Antwerpen, Belgium, 2060 | |
| Denmark | |
| Boehringer Ingelheim Investigational Site | |
| Vinderup, Denmark, DK-7830 | |
| Boehringer Ingelheim Investigational Site | |
| Vildbjerg, Denmark, DK-7480 | |
| Boehringer Ingelheim Investigational Site | |
| Herning, Denmark, DK-7400 | |
| Boehringer Ingelheim Investigational Site | |
| Haderslev, Denmark, DK-6100 | |
| Boehringer Ingelheim Investigational Site | |
| Rødovre, Denmark, DK-2610 | |
| Boehringer Ingelheim Investigational Site | |
| Christianfeld, Denmark, DK-6070 | |
| Boehringer Ingelheim Investigational Site | |
| Vildberg, Denmark, DK-7480 | |
| Boehringer Ingelheim Investigational Site | |
| Åbenrå, Denmark, DK-6200 | |
| Boehringer Ingelheim Investigational Site | |
| Hvidovre, Denmark, DK-2650 | |
| Boehringer Ingelheim Investigational Site | |
| Odder, Denmark, 8300 | |
| Finland | |
| Diacor | |
| Helsinki, Finland, FIN-00530 | |
| Kouvolan lääkäriasema | |
| Kouvola, Finland, FIN-45100 | |
| Hatanpään terveyskeskussairaala | |
| Tampere, Finland, FIN-33100 | |
| Kiljava Medical Research | |
| Hyvinkää, Finland, FIN-05800 | |
| Hämeenlinnan lääkäriasema Oy, Linnan klinikka | |
| Hämeenlinna, Finland, FIN-13100 | |
| Boehringer Ingelheim Investigational Site | |
| Jyväskylä, Finland, FIN-40100 | |
| France | |
| Hôpital de la Timone | |
| Marseille cedex 05, France, 13385 | |
| Boehringer Ingelheim Investigational Site | |
| Angers, France | |
| Boehringer Ingelheim Investigational Site | |
| Ay, France | |
| Boehringer Ingelheim Investigational Site | |
| Mayenne, France, 53100 | |
| Boehringer Ingelheim Investigational Site | |
| Jarny, France, 54800 | |
| Boehringer Ingelheim Investigational Site | |
| Château Gontier Bazougues, France, 53200 | |
| Germany | |
| Boehringer Ingelheim Investigational Site | |
| Straßkirchen, Germany, 94342 | |
| Boehringer Ingelheim Investigational Site | |
| Nürnberg, Germany, 90402 | |
| Boehringer Ingelheim Investigational Site | |
| Hatten, Germany, 26209 | |
| Boehringer Ingelheim Investigational Site | |
| Leipzig, Germany, 04329 | |
| Boehringer Ingelheim Investigational Site | |
| Marl, Germany, 45772 | |
| Boehringer Ingelheim Investigational Site | |
| Esslingen, Germany, 73733 | |
| Boehringer Ingelheim Investigational Site | |
| Rednitzhembach, Germany, 91126 | |
| Boehringer Ingelheim Investigational Site | |
| Rodgau-Dudenhofen, Germany, 63110 | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany, 12459 | |
| Boehringer Ingelheim Investigational Site | |
| Wallerfing, Germany, 94574 | |
| Boehringer Ingelheim Investigational Site | |
| Ellefeld, Germany, 08236 | |
| Boehringer Ingelheim Investigational Site | |
| Riesa, Germany, 01589 | |
| Boehringer Ingelheim Investigational Site | |
| Hagen, Germany, 58091 | |
| Evangelisches Krankenhaus | |
| Witten, Germany, 58455 | |
| Boehringer Ingelheim Investigational Site | |
| Ornbau, Germany, 91737 | |
| Boehringer Ingelheim Investigational Site | |
| Flörsheim, Germany, 65439 | |
| Deutsche Klinik für Diagnostik GmbH | |
| Wiesbaden, Germany, 65191 | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany, 13051 | |
| Boehringer Ingelheim Investigational Site | |
| Kelkheim, Germany, 65779 | |
| Boehringer Ingelheim Investigational Site | |
| Münster, Germany, 48155 | |
| Boehringer Ingelheim Investigational Site | |
| Werne, Germany, 59368 | |
| Boehringer Ingelheim Investigational Site | |
| Westerkappeln, Germany, 49492 | |
| Ireland | |
| Beaumont Park Clinic | |
| Dublin, Ireland, 9 | |
| Boehringer Ingelheim Investigational Site | |
| Kilkenny, Ireland | |
| Boehringer Ingelheim Investigational Site | |
| Dublin, Ireland, 7 | |
| Cardioperfect Research Room | |
| Dublin, Ireland, 8 | |
| Adelaide and Meath Hospitals (incorrporating NCH) | |
| Dublin, Ireland, 24 | |
| 19 Redwood View | |
| Dublin, Ireland, 24 | |
| Italy | |
| Università di Ferrara | |
| FERRARA, Italy, 44100 | |
| Ospedale Civile | |
| Vittorio Veneto (TV), Italy, 31029 | |
| Az. Osped. Universitaria "Osp. Riuniti" | |
| Foggia, Italy | |
| Ospedale S. Luigi - S. Currò | |
| CATANIA, Italy, 95100 | |
| Ospedale Scillesi d'America | |
| SCILLA (RC), Italy, 89058 | |
| Azienda Ospedaliera "Maggiore della Carità" | |
| NOVARA, Italy, 28100 | |
| Netherlands | |
| Boehringer Ingelheim Investigational Site | |
| Vaals, Netherlands | |
| Boehringer Ingelheim Investigational Site | |
| Ewijk, Netherlands, 6644 CL | |
| Boehringer Ingelheim Investigational Site | |
| Roelofarendsveen, Netherlands, 2371 RB | |
| Boehringer Ingelheim Investigational Site | |
| Rijswijk, Netherlands, 2281 AK | |
| Boehringer Ingelheim Investigational Site | |
| Beek en Donk, Netherlands, 5741 AR | |
| Boehringer Ingelheim Investigational Site | |
| Voerendaal, Netherlands | |
| Boehringer Ingelheim Investigational Site | |
| Oude Pekela, Netherlands, 9665 AR | |
| Boehringer Ingelheim Investigational Site | |
| Musselkanaal, Netherlands | |
| Boehringer Ingelheim Investigational Site | |
| Den Haag, Netherlands, 2585 LJ | |
| South Africa | |
| Boehringer Ingelheim Investigational Site | |
| Pretoria, South Africa, 0038 | |
| Spain | |
| Cardiology Service | |
| Santander, Spain, 39008 | |
| Hospital Gral de Jerez de la Frontera | |
| Jerez de la Frontera / Cádiz, Spain, 11407 | |
| Avda. Menendez Pidal, s&n | |
| Cordoba, Spain, 14004 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | BIL UK / Ireland |
More Information
| Study ID Numbers: | 502.400 |
| Study First Received: | October 14, 2005 |
| Last Updated: | October 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00240474 History of Changes |
| Health Authority: | Belgium: Directorate General for Medicinal Products; Denmark: Laegemiddelstyrelsen Clinical Studies; Finland: Lääkelaitos, National Agency for Medicines; France: French Medicine Agency (AFSSAPS); Germany: Bundesministerium für Arzneimittel und Medizinprodukte; Ireland: Irish Medicines Board; Italy: Comitato Etico dell'Azienda Ospedaliera "Arcispedale Sant'Anna" - Università di Ferrara; Netherlands: No regulatory agency approval needed for clinical trials; South Africa: Medicines Control Council; Spain: Agencia Española del Medicamento |
|
Anti-Infective Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Sodium Chloride Symporter Inhibitors Physiological Effects of Drugs Diuretics Calcium Channel Blockers Membrane Transport Modulators Therapeutic Uses Antifungal Agents Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan |
Benzoates Vascular Diseases Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions Amlodipine Protease Inhibitors Angiotensin II Type 1 Receptor Blockers Natriuretic Agents Hypertension |