Status:
COMPLETED
Pharmacodynamic Influences of Candesartan, Atenolol, Hydrochlorothiazide and Drug Combinations in Hypertensive Patients.
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Ottawa Hospital Research Institute
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
INTRODUCTION. Three large clinical trials (STOP-2, HOPE, LIFE) {Hansson, Lindholm, et al. 1999}{Dahlof, Devereux, et al. 2002}{Yusuf, Sleight, et al. 2000} have suggested that drugs that specifically...
Eligibility Criteria
Inclusion
- Mild to moderate essential hypertension as defined by a morning mean DBP \*90 mmHg and \* 109 mm Hg, a mean SBP \* 200 mm H for two consecutive visits (Visits 2 and 3) during the two-to-four week placebo run-in period,
- Ability to provide written informed consent.
Exclusion
- Any woman not surgically sterile or menopausal who:
- has a positive urine pregnancy test at screening (Visit 1) or baseline (Visit 3)
- is breast feeding
- Pre-menopausal women (last menstruation \< 1 year prior to start of run-in period) who:
- are not surgically sterile; and/or
- are of child-bearing potential and are NOT practicing acceptable means of birth control.
- Known or suspected secondary hypertension.
- Known reversible or non-reversible obstructive lung disease (e.g. asthma or COPD).
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- ALT or AST greater than 2.0 times the upper limit of reference range;
- Serum creatinine greater than 150 umol/L.
- Uncorrected volume depletion.
- NYHA functional class CHF III-IV (Refer to Appendices).
- Coronary heart disease needing pharmacological therapy.
- Stroke within the preceding six months.
- PTCA within the preceding three months.
- History of angioedema.
- Clinically significant sinus bradycardia below 55 beats/min. at randomization.
- Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical Investigator.
- Second or third degree AV block, left bundle branch block or any clinically relevant conduction abnormality as determined by the clinical Investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
- Administration of digoxin.
- Patients with a fasting glucose \> 7.0.
- Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, \*- blockers, \*-blockers, calcium channel antagonists, direct vasodilators that cannot be stopped for the trial.
- Administration of other non-antihypertensive medications known to affect blood pressure (e.g., oral corticosteroids, MAO inhibitors, nitrates) at any time during the trial.
- Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions.
- Uncorrected sodium depletion as defined by a serum sodium level less than 135 mEq/L.
- Clinically significant hyperkalemia as defined by serum potassium level greater than 5.2 mEq/L. Clinically significant hypokalemia as defined by serum potassium level less than 3.0 mEq/L.
- Patients receiving any investigational therapy within one month of signing the informed consent form.
- Known hypersensitivity to any component of candesartan, atenolol or hydrochlorothiazide.
- Any other clinical condition which, in the opinion of the principal Investigator, would not allow safe completion of the protocol and safe administration of trial medication.
- Known for allergy to sulfa or heparin
- Blood donation in the preceding 2 months
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00232882
Start Date
December 1 2003
End Date
April 1 2006
Last Update
September 4 2013
Active Locations (1)
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1
Institut de Recherches Cliniques de Montréal
Montreal, Quebec, Canada, H2W 1R7