A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis
Intervention: Olmesartan medoxomil (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
Summary
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.
Clinical Details
Official title: A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: The primary endpoint for the determination of efficacy will be a composite often 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: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or Females age less than or equal to 18
- TEE-defined Grade III or IV atherosclerotic disease of the thoracic aorta documented
within the previous 90 days, or established atherosclerotic disease of the lower
extremities as demonstrated by:
- a history of lower extremity peripheral vascular surgery for obstructive
atherosclerotic disease, or
- a history of lower extremity peripheral arterial angioplasty for obstructive
atherosclerotic disease, or
- a history of lower extremity amputation secondary to atherosclerotic disease, or
- an ABI <0. 90 within the previous 90 days, or
- a history of claudication in patients with documented coronary artery disease
(i. e., history of myocardial infarction, coronary revascularization, or coronary
angiography demonstrating at least one obstructive coronary lesion with a 50% or
greater stenosis).
Exclusion Criteria:
- Women of childbearing age who do not agree to utilize protocol approved contraceptive
methods.
- Average pre-dose SBP < 100 or DBP < 60.
- Patients with any serious disorder including cardiovascular (ventricular arrhythmias,
valvular disease or implantable defibrillator), renal, pulmonary, hepatic,
gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes
mellitus), hematologic/oncologic (including an active malignancy other than basal
cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric
diseases.
- Patients with a history of MI, PTCA, CABG, heart failure, CVA or TIA within the last
30 days.
Locations and Contacts
Additional Information
Starting date: June 2000
Last updated: September 27, 2006
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