Back to resultsA Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Olmesartan medoxomil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382213
Brief Title
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Official Title
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olmesartan medoxomil
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The primary endpoint for the determination of efficacy will be a composite of
Title
ten circulating surrogate markers of atherosclerosis for vascular inflammation.
Title
The surrogate markers of vascular inflammation to be used will include
Title
C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1, IL-6
Title
and MMP-9.
Secondary Outcome Measure Information:
Title
Individual circulating surrogate markers of atherosclerosis listed above
Title
(C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFα, IL-1, E-Selectin, ICAM-1,
Title
IL-6 and MMP).
Title
Serum levels of TGF-β, PDGF, HGF, and PAI-1.
Title
The ratio of reduced to oxidized glutathione in the plasma as an indicator
Title
of oxidative stress (GSH/GSSG ratio).
Title
Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
Title
Composite of chemoattractant markers (MCP-1, M-CSF).
Title
Composite of Growth Factor Markers (PDGF, HGF, TGF-β).
Title
Assessment of atherosclerotic disease severity of the thoracic aorta as
Title
determined by transesophageal echocardiography (TEE) in patients enrolled
Title
on the basis of TEE-defined aortic atherosclerosis.
Title
Assessment of atherosclerotic disease severity of the peripheral arteries
Title
of the lower extremities as determined by the ankle brachial index (ABI).
Title
Endothelial function as determined by brachial artery diameter responses to
Title
hyperemic flow.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis
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