Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patient written informed consent is signed prior to any trial specific procedures participation
male patients \> 18 years
Mean seated SBP \> 130mmHg and/or DBP \> 85mmHg treated with antihypertensive drug(s)
with at least 2 more criteria of metabolic syndrome (NCEPT III). Biological data available within 6 months prior to enrollment visit.
abdominal obesity \> 102 cm at screening
TG \> 1.5 g/l
HDL \< 0.4 g/l
Glycemia \> 6 mmol/l
You may not be if
Patients with any of the following conditions will be excluded from trial:
confirmed type 1 or 2 diabetic patients treated or not
secondary hypertension
Mean seated SBP\>180 mmHg and/or DBP \>110 mmHg at screening
hepatic and/or renal dysfunction as defined by the following laboratory parameters at visit 1:
SGPT (ALT) or SGOT (AST) ¿ twice the upper limit of the normal range
serum creatinine ¿ 2.3 mg/dL (or 203 ¿mol/L)
bilateral renal artery stenosis or renal artery stenosis in a solitary kidney
patients post-renal transplant or with only one functioning kidney
clinically relevant hypokalemia or hyperkalemia at visit 1
uncorrected volume or sodium depletion at visit 1
primary aldosteronism
hereditary or known fructose intolerance
biliary obstructive disorders
patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-II receptor antagonists
history of drug or alcohol dependency within the previous six months
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 less than three months prior to informed consent
stroke less than six 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
known allergic hypersensitivity to any component of the formulations under investigation
concomitant therapy with lithium, cholestyramine or colestipol resins continued after visit 1
