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

Boehringer Ingelheim

Status and phase: Completed; Phase 4

Conditions: Hypertension; Metabolic Syndrome X

Treatments: Procedure: Abdominal biopsy; Drug: Amlodipine; Drug: Micardis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00242814

502.486

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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