Description:

ODM derived from http://clinicaltrials.gov/show/NCT00240474

Link:

http://clinicaltrials.gov/show/NCT00240474

Keywords:
Versions (1) ▾
  1. 12/11/13
Uploaded on:

December 11, 2013

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00240474 Hypertension

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
aged at least 60 years old
mean SBP >140 mmHg and mean DBP <=95 mmHg
24-hour mean ambulatory SBP >125 mmHg
hypertensive patients not on current antihypertensive therapy or able to stop their current treatment for a period of up to eighteen weeks
willing and able to provide written informed consent
Exclusion Criteria
women of child-bearing potential who are NOT practicing acceptable means of birth control
known or suspected secondary hypertension
mean SBP >=200 mmHg
hepatic and/or renal dysfunction as defined by the following laboratory parameters: Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney. Clinically relevant hypokalemia or hyperkalemia. Uncorrected volume or sodium depletion.
Primary aldosteronism, unspecified
Hereditary fructose intolerance syndrome
Biliary Obstruction
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 the previous six months
chronic administration of any medication known to affect blood pressure, other than the trial medication
concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF II-IV)
unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery <3 months prior to informed consent
stroke <6 months prior to informed consent
sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator
hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for the previous three months
night-shift workers who routinely sleep during the daytime and whose working hours include midnight to 4:00 AM
known allergic hypersensitivity to any component of the formulations under investigation
concomitant therapy with lithium, cholestyramine or colestipol resins. non-compliance with study medication (defined as <80% or >120%) during the run-in period
current treatment with any antihypertensive agent
any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan, amlodipine or hydrochlorothiazide