Status and phase
Conditions
Treatments
About
The primary objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg [Micardis HCT] to valsartan 160 mg/hydrochlorothiazide 25 mg [Diovan HCT] and placebo in the treatment of Stage 1 and Stage 2 hypertension.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria
Exclusion criteria
Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:
Known or suspected secondary hypertension.
Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
Clinically relevant hypokalemia or hyperkalemia.
Uncorrected volume depletion.
Uncorrected sodium depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
History of drug or alcohol dependency within six months prior to start of run-in period.
Chronic administration of any medications known to affect blood pressure, etc.
Any investigational drug therapy within one month of start of run-in period.
known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
Night shift workers.
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
NYHA functional class CHF III-IV.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c >/= 10%.
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
History of non-compliance with prescribed medication or protocol procedures.
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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