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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00242814 |
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).
Condition | Intervention | Phase |
---|---|---|
Hypertension Metabolic Syndrome X |
Drug: Micardis Drug: Amlodipine Procedure: Abdominal biopsy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Enrollment: | 100 |
Study Start Date: | October 2005 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient written informed consent is signed prior to any trial specific procedures participation
Exclusion Criteria:
Patients with any of the following conditions will be excluded from trial:
France | |
502.486.3305A Cabinet Médical | |
Angers, France | |
502.486.3306A Cabinet Médical | |
Briollay, France | |
502.486.3307A Cabinet Médical | |
Chemille, France | |
502.486.3308A Cabinet Médical | |
Montrevault, France | |
502.486.3309A Cabinet Médical Jean Charcot | |
Segre, France | |
502.486.3310A Cabinet Médical | |
Saint Pierre Montlimard, France | |
502.486.3311A Cabinet Médical | |
Tierce, France | |
502.486.3311B Cabinet Médical | |
Tierce, France | |
502.486.3311C Cabinet Médical | |
Tierce, France | |
502.486.3302B Cabinet Médical | |
Angers, France | |
502.486.3312A Cabinet Médical | |
Feneu, France | |
502.486.3315A Cabinet Médical | |
La Rochelle, 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 | |
502.486.3311D Cabinet Médical | |
Tierce, France | |
502.486.3323A Cabinet Médical | |
Angers, France | |
502.486.3323B Cabinet Médical | |
Angers, France | |
502.486.3302A Cabinet Médical | |
Angers, France | |
502.486.3301B Hôpital Pitié Salpêtrière | |
Paris, 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 | |
502.486.3327A Cabinet Médical | |
Saumur, France | |
502.486.3328A Cabinet Médical | |
Angers, France | |
502.486 3301A Boehringer Ingelheim Investigational Site | |
Paris, France | |
502.486.3303A Boehringer Ingelheim Investigational Site | |
Angers, France | |
502.486.3316A Boehringer Ingelheim Investigational Site | |
Nieul sur Mer, France | |
502.486.3321A Cabinet Médical | |
Equeurdreville, France |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 502.486 |
Study First Received: | October 19, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00242814 |
Health Authority: | France: AFSSAPS |
Metabolic Syndrome X Metabolic Diseases Vascular Diseases Angiotensin II Amlodipine Hyperinsulinism Calcium, Dietary |
Syndrome X Insulin Resistance Telmisartan Glucose Metabolism Disorders Metabolic disorder Abdominal obesity metabolic syndrome Hypertension |
Vasodilator Agents Disease Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Pathologic Processes Syndrome Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |