NCT00242814

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hypertension
• Metabolic Syndrome X

Interventions

Type	Name	Description
DRUG	Micardis
DRUG	Amlodipine
PROCEDURE	Abdominal biopsy

Timeline

• Start date: 2005-11-03
• Primary completion: 2007-03-29
• First posted: 2005-10-21
• Last updated: 2023-12-08

Locations

31 sites across 1 country: France