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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00240474 |
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 |
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:
Study Chair: | Boehringer Ingelheim Study Coordinator | BIL UK / Ireland |
Study ID Numbers: | 502.400 |
Study First Received: | October 14, 2005 |
Last Updated: | July 6, 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 |
Vasodilator Agents Diuretics Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Cardiovascular Agents Angiotensin II Antihypertensive Agents |
Hydrochlorothiazide Protease Inhibitors Amlodipine Angiotensin II Type 1 Receptor Blockers Calcium, Dietary Angiotensin-Converting Enzyme Inhibitors Telmisartan Hypertension |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide |
Pharmacologic Actions Protease Inhibitors Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |