drugset / Trial / NCT00669435

Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

NCT00669435

Phase 4 Unknown 75 enrolled University of Pavia
RandomizedParallel-groupDouble-blindTreatment

Summary

Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.

Timeline

Start
2008-04
Primary completion
2008-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amlodipine Other / unclassified 5 mg
Comparator Amlodipine Other / unclassified 10 mg
Subject Losartan Other / unclassified 50 mg
Subject Losartan Other / unclassified 100 mg
Comparator Simvastatin Small molecule 20 mg

Indications