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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of the study is to compare PPAR activities (increase of adiponectin level) between MICARDIS and amlodipine after 6 weeks of treatment in hypertensive patients with metabolic syndrome. Moreover, this study will compare serum level of inflammatory markers of the metabolic syndrome after 6 weeks of treatment.

An ancillary study performed in one center will assess adipocyte differentiation (PPAR gamma stimulation) in 30 subjects (15 per arm).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Amlodipine; Telmisartan

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