Clinical trial NCT00242814: Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
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 With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Metabolic Syndrome X
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
timeFrame: At week 6
Secondary outcomes:
measure: 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.
timeFrame: At week 6
Other outcomes:
Locations:
city: Angers
country: France
facility: 502.486.3302A Cabinet Médical
city: Angers
country: France
facility: 502.486.3302B Cabinet Médical
city: Angers
country: France
facility: 502.486.3303A Boehringer Ingelheim Investigational Site
city: Angers
country: France
facility: 502.486.3305A Cabinet Médical
city: Angers
country: France
facility: 502.486.3323A Cabinet Médical
city: Angers
country: France
facility: 502.486.3323B Cabinet Médical
city: Angers
country: France
facility: 502.486.3324A Cabinet Médical
city: Angers
country: France
facility: 502.486.3324B Cabinet Médical
city: Angers
country: France
facility: 502.486.3325A Cabinet médical
city: Angers
country: France
facility: 502.486.3326A Cabinet Médical
city: Angers
country: France
facility: 502.486.3328A Cabinet Médical
city: Briollay
country: France
facility: 502.486.3306A Cabinet Médical
city: Chemille
country: France
facility: 502.486.3307A Cabinet Médical
city: Cherbourg
country: France
facility: 502.486.3319A Cabinet Médical
city: Cherbourg
country: France
facility: 502.486.3320A Cabinet Médical
city: Cherbourg
country: France
facility: 502.486.3320B Cabinet Médical
city: Equeurdreville
country: France
facility: 502.486.3321A Cabinet Médical
city: Evron
country: France
facility: 502.486.3322A Boehringer Ingelheim Investigational Site
city: Feneu
country: France
facility: 502.486.3312A Cabinet Médical
city: La Rochelle
country: France
facility: 502.486.3315A Cabinet Médical
city: Montrevault
country: France
facility: 502.486.3308A Cabinet Médical
city: Nieul sur Mer
country: France
facility: 502.486.3316A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 502.486 3301A Boehringer Ingelheim Investigational Site
city: Paris
country: France
facility: 502.486.3301B Hôpital Pitié Salpêtrière
city: Saint Pierre Montlimard
country: France
facility: 502.486.3310A Cabinet Médical
city: Saumur
country: France
facility: 502.486.3327A Cabinet Médical
city: Segre
country: France
facility: 502.486.3309A Cabinet Médical Jean Charcot
city: Tierce
country: France
facility: 502.486.3311A Cabinet Médical
city: Tierce
country: France
facility: 502.486.3311B Cabinet Médical
city: Tierce
country: France
facility: 502.486.3311C Cabinet Médical
city: Tierce
country: France
facility: 502.486.3311D Cabinet Médical
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: