A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

Atherosclerosis Clinical Trial

Official title:

A Randomized, Double Blind Study To Compare The Effects Of Olmesartan Medoxomil Versus Placebo In Patients With Established Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382213
• Other study ID #: 866-422 AIMS
• Status: Completed
• Phase: Phase 3
• Start date: June 2000
• Est. completion date: December 2004

Study information

• Verified date: May 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Olmesartan medoxomil

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint for the determination of efficacy will be a composite of
Primary	ten circulating surrogate markers of atherosclerosis for vascular inflammation.
Primary	The surrogate markers of vascular inflammation to be used will include
Primary	C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFa, IL-1, E-Selectin, ICAM-1, IL-6
Primary	and MMP-9.
Secondary	Individual circulating surrogate markers of atherosclerosis listed above
Secondary	(C-reactive protein, MCP-1, M-CSF, VCAM-1, TNFa, IL-1, E-Selectin, ICAM-1,
Secondary	IL-6 and MMP).
Secondary	Serum levels of TGF-ß, PDGF, HGF, and PAI-1.
Secondary	The ratio of reduced to oxidized glutathione in the plasma as an indicator
Secondary	of oxidative stress (GSH/GSSG ratio).
Secondary	Composite of adhesion markers (VCAM-1, E-selectin, and ICAM-1).
Secondary	Composite of chemoattractant markers (MCP-1, M-CSF).
Secondary	Composite of Growth Factor Markers (PDGF, HGF, TGF-ß).
Secondary	Assessment of atherosclerotic disease severity of the thoracic aorta as
Secondary	determined by transesophageal echocardiography (TEE) in patients enrolled
Secondary	on the basis of TEE-defined aortic atherosclerosis.
Secondary	Assessment of atherosclerotic disease severity of the peripheral arteries
Secondary	of the lower extremities as determined by the ankle brachial index (ABI).
Secondary	Endothelial function as determined by brachial artery diameter responses to
Secondary	hyperemic flow.