Official Title: “A Phase IV Study, Prospective, Randomised, Open Label, Blinded Endpoint, Parallel Group, 9 Weeks of Comparison Between Oral Administration of Telmisartan Tablet (80mg Once Daily) and Amlodipine Tablet (10 mg Once Daily) on Biological PPAR Gamma Activities in Non Controlled Hypertensive Male Patients”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control, Parallel Assignment

Intervention(s) in this Clinical Trial

• Drug: Micardis
• Drug: Amlodipine
• Procedure: Abdominal biopsy

Primary Measures

• Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.

Secondary Measures

• Comparison of serum level of TNF alpha, IL-6, leptine, hsCRP, TG, HDL and blood pressure control between two groups. Adipocyte differentiation in 30 patients (PPAR gamma stimulation) between two groups.

• 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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Boehringer Ingelheim Pharmaceuticals  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242814

Study ID Number: 502.486

ClinicalTrials.gov Identifier: NCT00242814

Health Authority: France: AFSSAPS