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| Sponsor: | Institut de Recherches Cliniques de Montreal |
|---|---|
| Collaborator: |
Ottawa Hospital Research Institute |
| Information provided by: | Institut de Recherches Cliniques de Montreal |
| ClinicalTrials.gov Identifier: | NCT00232882 |
Purpose
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 Thiazide Drug: Atenolol Thiazide Drug: Thiazide Candesartan |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Neurohumoral and Oxidative Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Essential Hypertensive Patients. |
| Enrollment: | 86 |
| Study Start Date: | December 2003 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Candesartan 16 mg for 4 weeks followed by candesartan 16 mg and hydrochlorothiazide 12.5 mg for 4 weeks
|
Drug: Candesartan Thiazide
Candesartan 16 mg for 4 weeks then added hydrochlorothiazide for 4 weeks
|
|
Active Comparator: 2
Atenolol 100 mg for 4 weeks followed by atenolol 100 mg + hydrochlorothiazide 12.5 mg for 4 weeks
|
Drug: Atenolol Thiazide
Atenolol 100 mg for 4 weeks followed by atenolol 100 mg + hydrochlorothiazide 12.5 mg for 4 weeks
|
|
Active Comparator: 3
Thiazide 25 mg for 4 weeks then added with Candesartan 16 mg
|
Drug: Thiazide Candesartan
Thiazide 25 mg for 4 weeks then added with Candesartan 16 mg
|
Show Detailed Description
Eligibility| 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:
Contacts and Locations| Canada, Quebec | |
| Institut de Recherches Cliniques de Montréal | |
| Montréal, Quebec, Canada, H2W 1R7 | |
| Principal Investigator: | Maxime Lamarre-Cliche, MD | Institut de Recherches Cliniques de Montreal |
More Information
| Responsible Party: | Maxime Lamarre-Cliche, Institut de Recherches Cliniques de Montreal |
| ClinicalTrials.gov Identifier: | NCT00232882 History of Changes |
| Other Study ID Numbers: | D2452L00003 |
| Study First Received: | October 3, 2005 |
| Last Updated: | July 4, 2011 |
| Health Authority: | Canada: Health Canada |
|
Hypertension Blood pressure Antihypertensive drugs Clinical Pharmacology |
Autonomic nervous system Renin angiotensin system Oxidative stress Inflammatory markers |
|
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan Candesartan cilexetil Antihypertensive Agents Atenolol Hydrochlorothiazide Sodium Chloride Symporter Inhibitors Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Anti-Arrhythmia Agents Sympatholytics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Membrane Transport Modulators Diuretics Natriuretic Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |