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| 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
Show 73 Study Locations| Study Chair: | Boehringer Ingelheim Study Coordinator | BIL UK / Ireland |
More Information
| ClinicalTrials.gov Identifier: | NCT00240474 History of Changes |
| Other Study ID Numbers: | 502.400 |
| Study First Received: | October 14, 2005 |
| Last Updated: | October 7, 2009 |
| 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 |
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Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Amlodipine Telmisartan Telmisartan, hydrochlorothiazide drug combination Benzoates Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Chloride Symporter Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Calcium Channel Blockers Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents |