Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities

Launched by BOEHRINGER INGELHEIM · Oct 20, 2005

Keywords

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• 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