A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
The purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an Angiotensin Receptor Blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. Patients will be randomized to receive either olmesartan medoxomil or placebo for one year.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis|
- The primary endpoint for the determination of efficacy will be a composite of
- ten circulating surrogate markers of atherosclerosis for vascular inflammation.
- The surrogate markers of vascular inflammation to be used will include
- C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6
- and MMP-9.
- Individual circulating surrogate markers of atherosclerosis listed above
- (C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,
- IL-6 and MMP).
- Serum levels of TGF-β, PDGF, HGF, and PAI-1.
- The ratio of reduced to oxidized glutathione in the plasma as an indicator
- of oxidative stress (GSH/GSSG ratio).
- Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
- Composite of chemoattractant markers (MCP-1, M-CSF).
- Composite of Growth Factor Markers (PDGF, HGF, TGF-β).
- Assessment of atherosclerotic disease severity of the thoracic aorta as
- determined by transesophageal echocardiography (TEE) in patients enrolled
- on the basis of TEE-defined aortic atherosclerosis.
- Assessment of atherosclerotic disease severity of the peripheral arteries
- of the lower extremities as determined by the ankle brachial index (ABI).
- Endothelial function as determined by brachial artery diameter responses to
- hyperemic flow.
|Study Start Date:||June 2000|
|Estimated Study Completion Date:||December 2004|