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Sponsored by: |
Institut de Recherches Cliniques de Montreal |
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Information provided by: | Institut de Recherches Cliniques de Montreal |
ClinicalTrials.gov Identifier: | NCT00232882 |
Angiotensin receptor antagonists (ARA), beta-blockers and diuretics do not seem to confer equivalent cardiovascular protection in hard outcomes clinical trials (beta blockers inferior). These results may be explained by differences in their effects on sympathetic activity, oxidative stress, inflammation and renin angiotensin system activation.
How diuretic addition to first line therapy with ARAs and beta-blockers modulates neurohumoral and hemodynamic parameters is not well understood.
The main hypothesis of this study is that an ARA (candesartan) combined or not with a diuretic will not increase sympathetic activity as much as a beta blocker (atenolol). Secondary hypothesis are of similar nature but relate to hemodynamic parameters, oxidative stress markers, inflammatory markers, or the renin angiotensin system.
The main objective of this study is to assess and compare the effects of candesartan and atenolol and their combination with low dose diuretic therapy on the autonomic nervous system, hemodynamic parameters,on oxidative stress, on inflammatory markers, and on the renin-angiotensin system.
Protocol sponsored by Astra Zeneca canada
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Candesartan, hydrochlorothiazide, atenolol, combinations |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Neurohumoral and Oxidative Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Essential Hypertensive Patients. |
Estimated Enrollment: | 54 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any woman not surgically sterile or menopausal who:
Pre-menopausal women (last menstruation < 1 year prior to start of run-in period) who:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Contact: Maxime Lamarre-Cliche, MD | (514) 987-5550 | lamarrm@ircm.qc.ca |
Contact: Pierre Larochelle, MD | (514) 987-5550 | Pierre.Larochelle@ircm.qc.ca |
Canada, Quebec | |
Institut de Recherches Cliniques de Montréal | Recruiting |
Montréal, Quebec, Canada, H2W 1R7 | |
Contact: Maxime Lamarre-Cliche, MD (514) 987-5550 lamarrm@ircm.qc.ca | |
Contact: Pierre Larochelle, MD (514) 987-5550 Pierre. Larochelle@ircm.qc.ca | |
Principal Investigator: Maxime Lamarre-Cliche, MD | |
Sub-Investigator: Pierre Larochelle, MD | |
Sub-Investigator: Jacques De Champlain, MD | |
Sub-Investigator: Ernesto L Schiffrin, MD | |
Sub-Investigator: Rhian Thouyz, MD |
Principal Investigator: | Maxime Lamarre-Cliche, MD | Institut de Recherches Cliniques de Montreal |
Study ID Numbers: | D2452L00003, D2452L00003 |
Study First Received: | October 3, 2005 |
Last Updated: | October 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00232882 |
Health Authority: | Canada: Health Canada |
Hypertension Blood pressure Antihypertensive drugs Clinical Pharmacology |
Autonomic nervous system Renin angiotensin system Oxidative stress Inflammatory markers |
Candesartan cilexetil Candesartan Vascular Diseases Stress |
Angiotensin II Atenolol Hydrochlorothiazide Hypertension |
Sympatholytics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sodium Chloride Symporter Inhibitors Diuretics Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents |