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

Phase 4

Completed

• Conditions: Metabolic Syndrome X; Hypertension

• Registration Number: NCT00242814
• Lead Sponsor: Boehringer Ingelheim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-19
• Study First Submitted QC: 2005-10-20
• Study First Posted: 2005-10-21
• Study Start: 2005-11-03
• Primary Completion: 2007-03-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.	At week 6

Secondary Outcome Measures

Name	Time	Method
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.	At week 6

Trial Locations

Locations (31)

502.486.3302A Cabinet Médical; 🇫🇷 Angers, France

502.486.3323A Cabinet Médical; 🇫🇷 Angers, France

502.486.3307A Cabinet Médical; 🇫🇷 Chemille, France

502.486.3302B Cabinet Médical; 🇫🇷 Angers, France

502.486.3303A Boehringer Ingelheim Investigational Site; 🇫🇷 Angers, France

502.486.3324B Cabinet Médical; 🇫🇷 Angers, France

502.486.3305A Cabinet Médical; 🇫🇷 Angers, France

502.486.3324A Cabinet Médical; 🇫🇷 Angers, France

502.486.3323B Cabinet Médical; 🇫🇷 Angers, France

502.486.3308A Cabinet Médical; 🇫🇷 Montrevault, France

502.486.3310A Cabinet Médical; 🇫🇷 Saint Pierre Montlimard, France

502.486 3301A Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

502.486.3321A Cabinet Médical; 🇫🇷 Equeurdreville, France

502.486.3315A Cabinet Médical; 🇫🇷 La Rochelle, France

502.486.3311C Cabinet Médical; 🇫🇷 Tierce, France

502.486.3325A Cabinet médical; 🇫🇷 Angers, France

502.486.3326A Cabinet Médical; 🇫🇷 Angers, France

502.486.3328A Cabinet Médical; 🇫🇷 Angers, France

502.486.3306A Cabinet Médical; 🇫🇷 Briollay, France

502.486.3319A Cabinet Médical; 🇫🇷 Cherbourg, France

502.486.3320A Cabinet Médical; 🇫🇷 Cherbourg, France

502.486.3320B Cabinet Médical; 🇫🇷 Cherbourg, France

502.486.3322A Boehringer Ingelheim Investigational Site; 🇫🇷 Evron, France

502.486.3312A Cabinet Médical; 🇫🇷 Feneu, France

502.486.3301B Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

502.486.3316A Boehringer Ingelheim Investigational Site; 🇫🇷 Nieul sur Mer, France

502.486.3327A Cabinet Médical; 🇫🇷 Saumur, France

502.486.3309A Cabinet Médical Jean Charcot; 🇫🇷 Segre, France

502.486.3311A Cabinet Médical; 🇫🇷 Tierce, France

502.486.3311B Cabinet Médical; 🇫🇷 Tierce, France

502.486.3311D Cabinet Médical; 🇫🇷 Tierce, France