Phase IV, 9 Weeks Comparison Between MICARDIS 80 mg and Amlodipine 10 mg on Biological PPAR Gamma Activities
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|ClinicalTrials.gov Identifier: NCT00242814|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : May 21, 2012
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 or disease||Intervention/treatment||Phase|
|Hypertension Metabolic Syndrome X||Drug: Micardis Drug: Amlodipine Procedure: Abdominal biopsy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|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 Start Date :||October 2005|
|Actual Primary Completion Date :||March 2007|
- Comparison of the serum adiponectin level at the end of study (6 weeks) between the two groups.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242814
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|