Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Metabolic Syndrome X
Intervention: Micardis (Drug); Amlodipine (Drug); Abdominal biopsy (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
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).
Clinical Details
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 design: Primary Purpose: Treatment
Primary outcome: Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
502.486.3302A Cabinet Médical, Angers, France
502.486.3302B Cabinet Médical, Angers, France
502.486.3303A Boehringer Ingelheim Investigational Site, Angers, France
502.486.3305A Cabinet Médical, Angers, France
502.486.3323A Cabinet Médical, Angers, France
502.486.3323B Cabinet Médical, Angers, France
502.486.3324A Cabinet Médical, Angers, France
502.486.3324B Cabinet Médical, Angers, 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
502.486.3307A Cabinet Médical, Chemille, France
502.486.3319A Cabinet Médical, Cherbourg, France
502.486.3320A Cabinet Médical, Cherbourg, France
502.486.3320B Cabinet Médical, Cherbourg, France
502.486.3321A Cabinet Médical, Equeurdreville, France
502.486.3322A Boehringer Ingelheim Investigational Site, Evron, France
502.486.3312A Cabinet Médical, Feneu, France
502.486.3315A Cabinet Médical, La Rochelle, France
502.486.3308A Cabinet Médical, Montrevault, France
502.486.3316A Boehringer Ingelheim Investigational Site, Nieul sur Mer, France
502.486 3301A Boehringer Ingelheim Investigational Site, Paris, France
502.486.3301B Hôpital Pitié Salpêtrière, Paris, France
502.486.3310A Cabinet Médical, Saint Pierre Montlimard, 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
502.486.3311C Cabinet Médical, Tierce, France
502.486.3311D Cabinet Médical, Tierce, France
Additional Information
Starting date: October 2005
Last updated: May 18, 2012
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