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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 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:

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

Page last updated: August 20, 2015

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