A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
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|ClinicalTrials.gov Identifier: NCT00382213|
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : September 28, 2006
Daiichi Sankyo, Inc.
Information provided by:
Daiichi Sankyo, Inc.
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: Olmesartan medoxomil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis|
|Study Start Date :||June 2000|
|Estimated Study Completion Date :||December 2004|
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
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